CN115397489A - Electronic system for drug delivery device and drug delivery device - Google Patents

Abstract

An electronic system (1000) for a drug delivery device (1,2) is provided, the electronic system comprising: -a dose setting and driving mechanism (1780, 1790) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose, the dose setting and driving mechanism comprising a first member (1780) and a second member (1790), wherein the dose setting and driving mechanism is configured such that, in the dose delivery operation and/or in the dose setting operation, the first member is moved, e.g. rotated, relative to the second member; -an electronic control unit (1100) configured to control operation of an electronic system, the electronic system having a first state and a second state, wherein the electronic system has an increased power consumption in the second state compared to the first state; -an electrical usage detection unit (1300) operatively connected to the electronic control unit, the electrical usage detection unit being configured to generate a usage signal indicating that a user has started a dose setting operation or a dose delivery operation, wherein the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the usage signal, and wherein the electrical usage detection unit is configured to generate the usage signal in response to a relative movement, e.g. in response to a relative rotational movement therebetween, between the first member and the second member, preferably during a dose delivery operation.

Description

Electronic system for drug delivery device and drug delivery device

Background technique

The present disclosure relates to an electronic system for a drug delivery device. The present disclosure further relates to a drug delivery device, preferably comprising said electronic system.

Drug delivery devices using electronics are becoming more and more popular in the pharmaceutical industry and for users or patients. However, especially if the device is designed as a stand-alone (that is to say without connectors for connection to the power source necessary to provide power for the operation of the device), the management of power supply resources integrated into the device is particularly important.

Contents of the invention

It is an object of the present disclosure to provide improvements in drug delivery devices comprising one or more electronic systems for the drug delivery device.

This object is achieved by the subject-matter defined in the independent claims. Advantageous embodiments and developments are subject to the subclaims. It should be noted, however, that the present disclosure is not limited to the subject matter defined in the appended claims. Rather, as will become apparent from the following description, the disclosure may comprise improvements in addition to or instead of the subject matter defined in the independent claims.

One aspect of the present disclosure relates to an electronic system for a drug delivery device. Another aspect of the disclosure relates to a drug delivery device comprising said electronic system. Accordingly, features described herein in relation to a drug delivery device should be considered as disclosed for an electronic system, and vice versa.

In one embodiment, the electronic system or drug delivery device includes a dose setting and/or drive mechanism. The dose setting mechanism may be configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device. The dose that can be set in the drug delivery device can be a variable dose, ie the size of the dose that can be set is not fixed by the design of the mechanism but can be selected by the user. Preferably, the user can select a set dose between a minimum settable dose and a maximum settable dose. The drive mechanism may be configured to perform a dose delivery operation for delivering said dose (eg a previously set dose).

In one embodiment, the electronic system of the drug delivery device comprises a housing. The housing may house components of the dose setting and/or drive mechanism and/or one or more other components of the electronic system or drug delivery device. The housing may be an outer housing. That is, the housing may present the outer surface of the electronic system or drug delivery device. Components described herein as moving may move relative to the housing during operation of the electronics and/or dose setting and/or drive mechanism.

In one embodiment, the dose setting and/or drive mechanism comprises user interface members, eg dose and/or injection buttons. The user interface member may be arranged to be operated by a user to operate the mechanism.

In one embodiment, the dose setting and/or drive mechanism comprises a first member and a second member. The first member and/or the second member may be configured to move relative to the electronic system or the housing of the drug delivery device during a dose setting operation and/or during a dose delivery operation. The first member may be a dose member or a dial member (eg a dial sleeve or number sleeve) of the dose setting and/or drive mechanism moved to set a dose. The second member may be a drive member (eg a member that engages with a dose setting and/or a piston rod of the drive mechanism) or a user interface member (eg a dose and/or injection button). The first member and/or the second member may be movably coupled to or retained in the housing. During a dose setting operation, the first member and/or the second member may be displaced axially (eg away from the proximal end of the housing) relative to the housing. The distance by which the first member and/or the second member are axially displaced relative to the housing during a dose setting operation may be determined by the size of the set dose. In other words, the drug delivery device may be of the dial extension type, ie the device increases in length during a dose setting operation by an amount proportional to the size of the set dose.

In one embodiment, the first member moves (eg rotates and/or moves axially) relative to the second member during a dose setting operation and/or during a dose delivery operation. For example, the first member may rotate relative to the second member during a dose delivery operation. Both the first member and the second member are axially movable during a dose delivery operation. During a dose setting operation and/or a dose delivery operation, the first member may rotate relative to the second member and relative to the housing. During a dose delivery operation, the second member may be rotationally locked or guided relative to the housing, for example by a delivery adapter. The first member and the second member may be rotationally locked relative to each other during a dose setting operation. Thus, the first member and the second member may rotate relative to the housing during a dose setting operation. During a dose setting operation, the first member and the second member may be coupled to each other eg via a coupling interface (eg a setting adapter). The coupling interface may rotationally lock the first member and the second member to each other during a dose setting operation. When the coupling interface is engaged, the first member and the second member may be rotationally locked to each other, such as by direct engagement of a coupling interface feature. The first component and the second component may include matching coupling interface features. The coupling interface is releasable during the dose delivery operation. In particular, the usage signal explained in more detail below may only occur when the coupling interface (e.g., the delivery adapter and/or the setting adapter) has changed its state (e.g., from engaged to released or vice versa) and/or Generated after the first member has been rotated relative to the second member.

In one embodiment, the first member and the second member rotate relative to each other during only one of the dose setting operation and the dose delivery operation. One of the first member and the second member is rotatable relative to the housing during both operations. One of the first member and the second member may rotate relative to the housing during only one of these operations, eg during dose setting or during dose delivery.

In one embodiment, the device or electronic system comprises an electronic control unit, eg comprising a microprocessor or microcontroller. The electronic control unit may be configured to control the operation of the drug delivery device or electronic system. The electronic control unit can be arranged on the conductor carrier and be electrically conductively connected to the conductors on the conductor carrier. The conductor carrier may be a circuit board, such as a printed circuit board. The conductor carrier may be held in the interior of a user interface member of a system or device.

In one embodiment, the device or electronic system includes a power source. The power supply may be arranged in the interior of the electronic system, such as in the interior of the user interface member.

In one embodiment, an electronic system has a first state and a second state. The first state and the second state may be different operating states of the electronic system. In the first state, the system may be in an idle state in which the system is not operating with a desired function (e.g., a dose recording function) assigned to the electronic system during dose setting and/or dose delivery operations . In the second state, the system may be ready to operate with a desired function, in particular when a dose setting operation and/or a dose delivery operation is being performed in the second state. Compared with the first state, the power consumption of the electronic system in the second state may be increased. For example, in a second state, one or more electrical or electronic units of the electronic system may be switched to a state (for example, an on state) with higher power consumption compared to the first state, in which , the corresponding unit may be in a sleep state with low power consumption or an disconnected state with no power consumption at all, for example because the connection to the power supply is cut off.

In one embodiment, an electronic system includes a power usage detection unit. The usage detection unit may for example be operatively connected to the electronic control unit in an electrically conductive manner, eg via conductors on the conductor carrier. The electricity usage detection unit may be configured to generate or trigger a usage signal (eg, an electrical signal). The usage signal may indicate to the user that a dose setting operation or a dose delivery operation has been initiated. Initiating a dose setting operation or a dose delivery operation may require relative movement (eg relative rotational movement) between the first member and the second member. Accordingly, the use signal may only be generated after a dose setting operation or a dose delivery operation has been started or initiated. In this way, it can be ensured that when a use signal is generated, the operation it should indicate, such as a dose setting operation or a dose delivery operation, has already started.

In one embodiment, the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the use signal. Accordingly, the generation of the usage signal may cause and cause the electronic system to switch to the second state with increased power consumption. The electronic control unit may, in response to receiving the use signal, issue a command (eg, a signal) to another unit of the electronic system such that the unit is turned on or operable. This unit may be a motion sensing unit configured to measure how much the first member has moved relative to the second member during a dose setting operation and/or a dose delivery operation. The movement may indicate the currently set or delivered dose.

In one embodiment, the usage detection unit is configured to generate the usage signal in response to relative movement (eg relative rotational movement) between the first member and the second member, conveniently during a dose delivery operation. Therefore, relative movement between the first and second members may be required to generate the use signal. This means that a dose setting or dose delivery operation is actually being performed and therefore it is likely that the system is being operated intentionally. This is especially the case when the usage signal is only generated during a dose delivery operation, eg when the delivery operation has started.

In one embodiment, the first component is a component other than the user interface component. In particular, the first member may not have any surface intended to be touched by a user for operating the drug delivery device or system. The first component may be an internal component of the drug delivery device or system. The first member may be arranged within a housing of the drug delivery device.

In one embodiment, the dose setting and/or drive mechanism comprises a dose member, eg a number sleeve or a dial sleeve. The dose member is rotatable relative to the housing during a dose setting operation, eg by integer multiples of unit set increments. The dose member may be operatively coupled (eg rotationally locked) to the user interface member and/or the second member during a dose setting operation. The unit setting increment may be a constant angle. Thus, the unit setting increment may define the minimum dose that can be set by the dose setting and/or drive mechanism. One unit set increment may correspond to a rotation greater than or equal to 10° and/or a rotation less than or equal to 20° (eg, 15°). The electronic system may include an incremental change setting interface defining unit setting increments. The setting interface may be a ratchet interface. For example, a ratchet interface may operate between the dose member and the housing.

In one embodiment, the axis of rotation about which one, more or all of the rotations discussed herein is performed may be the longitudinal axis of the housing and/or the first member and/or the second member at dose setting and and/or an axis of rotation about which to rotate eg relative to the housing during dose delivery.

In one embodiment, one of the first member and the second member is a dosage member. Alternatively, the first member and the second member are different from the dose member.

In one embodiment, at least a portion of the second member is received within the first member.

In one embodiment, the first member and/or the second member or a portion of the respective member has a sleeve-like configuration.

In one embodiment, the electronic system is configured such that the use signal is preferably generated only after rotation of the first member relative to the housing and/or the second member has started. Before the first member has rotated relative to the second member and/or the housing by two unit setting increments, preferably after the first member has rotated relative to the second member and/or housing by more than one unit setting A usage signal can be generated before the increment.

In one embodiment, the electronic system is configured such that the electronic system moves from the first to the second member before the relative rotation between the first member and the second member reaches two unit set increments, preferably one unit set increment. The transition from the state to the second state has been completed. Therefore, the wake-up process for switching the system to the second state with higher power consumption can be completed quickly. This means that the motion sensing unit can eg be operated very soon after a dose setting operation or a dose delivery operation is initiated.

In one embodiment, the electronic system is configured such that switching of the system from the first state to the second state is accomplished within a time span less than or equal to one of the following: 5 ms, 4 ms, 3.5 ms, 3.2 ms, 3 ms , 2.8ms, 2.7ms, 2.5ms (ms: milliseconds). Alternatively or additionally, the electronic system is configured such that switching of the system from the first state to the second state is accomplished within a time span greater than or equal to one of the following: 1 ms, 1.5 ms, 1.7 ms, 2.0 ms , 2.2ms, 2.5ms. Specifically, the time span required for the system to switch from the first state to the second state may be between 1 ms and 5 ms. The time span required for switching may start from the generation of the usage signal or from the movement of the user interface member for performing a dose setting operation or a dose delivery operation until the time when the motion sensing unit and/or communication unit has become operable. Sure.

In one embodiment, relative rotation of the first member and the second member during a dose delivery operation may be indicative of the size of the dose being dispensed during a dose delivery operation or being set during a dose setting operation. Hence, since the usage signal is only generated after the rotation has started, an offset is taken into account when the dose should be calculated from the measured relative rotation. Said offset may be a unit set increment which must be added to the measured dose when this dose is required to activate the electronic system and in particular its set and/or dispensed dose measuring and/or recording capabilities. Set increments in the units described above.

In one embodiment, the electronic system includes a use signal generating interface, eg including a ratchet interface such as a radial ratchet interface or an axial ratchet interface. The usage signal generating interface may be configured to generate one or more usage signals in response to relative rotation between the first member and the second member. The usage signal generation interface may be configured to generate one (eg only one) or more usage signals during a dose delivery operation. In case more than one usage signal is generated, preferably the first generated usage signal is a signal for triggering the electronic system to switch from the first state to the second state. Using a signal generating interface may be an incrementally changing interface. Use a signal to generate deltas that can be angles. Use signal generation increments that can be adjusted to unit setting increments. Preferably, the use signal generation increment is equal to or smaller than the unit set increment. That is, the intervals using signal generation increments and the intervals of unit setting increments may be equal, or the intervals using signal generation increments may be finer. At finer pitches, one unit set increment of rotation can cover more than one using signal generation increment.

In one embodiment, an electronic system includes a use signal generating interface component. A ratchet (eg, having ratchet teeth and/or ratchet recesses) for the use signal generation interface may be provided on the use signal generation interface member. The ratchet teeth and/or the ratchet recesses of the ratchet can be oriented axially or radially. That is, the free ends of the teeth may point in a radial direction. The usage signal generating interface component may be a separate component from the first component and the second component. Alternatively, the use signal generation interface component may be one of the first component and the second component, for example, the first component. The signal generating interface member is rotationally lockable to one of the first member and the second member. Using the signal generating interface the member may be axially movable relative to the member to which it is connected eg in a limited manner (eg rotationally locked). Using the signal generating interface the member may be axially lockable to the other of the first member and the second member, eg to the second member.

In one embodiment, the electronic system or drug delivery device includes a moveable switch feature. The switch feature may be movable along and/or transverse or radial to the rotational axis or main longitudinal axis of the housing. The switch feature is rotationally lockable to one of the second ones of the first members, preferably to the second member. The switch feature may be arranged to move only radially, or only axially, or both radially and axially. The switch feature can be rigid or preferably elastically deformable. The switch feature may be operatively coupled to one of the first member and the second member, eg, via use of a signal generating interface member. For example, a switch feature may engage a ratchet (eg, define a ratchet that generates increments using a signal). The switch feature may be operatively coupled to the first member and/or the second member such that rotation of the first member relative to the second member causes the switch feature to move relative to the first member, relative to the second member and/or relative to the housing. of the mobile. For example, rotation of the first member relative to the second member, relative to the switch feature and/or relative to the housing may be translated into movement of the switch feature, eg, by an operative coupling between the switch feature and the ratchet. Alternatively, rotation of the first member relative to the switch feature may remove a mechanical stop blocking movement of the switch feature in the direction in which the switch feature is biased. Movement of the switch feature can be used to trigger generation of a usage signal. In other words, generating the use signal may require movement of the switch feature in response to movement of the first member relative to the second member. For example, movement of a switch feature may be used and/or cause a change in state of an electrical connection (eg, from open to closed, or vice versa) and/or may trigger an electrical switch in order to generate or trigger a use signal. The switch feature can be electrically insulating (eg, plastic), or it can be conductive (eg, metallic). If the switch feature is conductive, the switch feature may form part of an electrical switch (eg a contact feature of the switch) brought into electrical contact with another contact feature of the switch to generate the use signal.

In one embodiment, the switch feature engages a ratchet (eg, a ratchet that may be associated with the first member or the second member). The switch feature may be biased into engagement with the ratchet, for example when the switch feature has been displaced out of a ratchet recess defined between two adjacent ratchet teeth of the ratchet. The biasing force acting on the switch feature may act against the direction of movement of the switch feature causing generation of the usage signal. In order to generate a use signal, the switch feature can eg be moved radially inwards. In an initial state, before commencing a dose setting operation or a dose delivery operation, the switch feature may engage a ratchet recess defined by adjacent ratchet teeth, such as the teeth of the ratchet defining the usage signal generating interface.

In one embodiment, the switch feature is preferably resiliently biased under a biasing force to align with the blocking feature prior to movement of the first member relative to the second member and/or prior to commencing a dose setting operation or a dose delivery operation. join. The blocking feature may block movement of the switch feature relative to the housing, the first member and/or the second member in the direction of the biasing force. The biasing force may be provided by, for example, an electrical contact feature of a switch that is resiliently displaced prior to commencing a dose setting operation and/or a dose delivery operation. The blocking feature may be provided by ratchet teeth between two adjacent ratchet recesses. The biasing force may act in the direction of movement causing generation of the usage signal. For example, the switch feature cooperates with the blocking feature to maintain the switch in the open state. When the blocking feature is removed from the switch feature, the bias can be released and the switch can be closed. In order to generate a use signal at the start of a dose setting operation or a dose delivery operation, for example, the switch feature may be moved in a radially outward direction.

In one embodiment, the electronic system or drug delivery device is configured such that movement of the switch feature is used to trigger the electrical switch, eg by touching and/or moving the trigger feature of the switch. When the switch is triggered, a use signal may be generated. In response to the use signal, the electronic control unit may switch the electronic system from the first state to the second state.

In one embodiment, the switch feature is linearly guided. For example, switch features may be received in guide slots. The switch feature may only move linearly (eg radially or axially) when it is guided linearly. This provides a relatively simple type of movement when triggered using signals. For example, a guide groove may be provided in the second member.

In one embodiment, the switching feature is oriented in particular axially along the axis of rotation, or in particular radially or transversely with respect to the axis of rotation.

In one embodiment, the switch feature is pivotally mounted, particularly within an electronic system or drug delivery device. The movement of the switch feature causing generation of the usage signal may be a pivotal movement. The switch feature may be pivotally mounted to the second member.

In one embodiment, the switch feature moves transversely and/or along an axis of rotation about which the first member is relative to the second member and/or relative to the housing during a dose setting operation and/or a dose delivery operation body rotation.

In one embodiment, the switch feature is pin-shaped and/or has a main direction of extension.

In one embodiment, the switch feature has a portion of U-shaped cross-section, especially when the cross-section is taken parallel to the axis of rotation.

In one embodiment, one of the first member and the second member is provided with a ratchet. The switch feature may be arranged to cooperate mechanically with the ratchet. A ratchet may be provided on the first member. A ratchet can be provided on the use signal generating interface component. The ratchet may include circumferentially or angularly disposed ratchet teeth. The ratchet teeth can be evenly distributed in the circumferential direction or in the angular direction. Two adjacent teeth may be separated by a ratchet recess. The ratchet teeth may be oriented axially (eg, proximally) or radially (eg, inwardly).

In one embodiment, the switch feature is biased into engagement with the ratchet recess as it attempts to disengage said ratchet recess. The biasing may be provided by an elastically displaceable feature and/or an electrical contact feature of the switch.

In one embodiment, the electronic system or drug delivery device comprises a plurality of switch features, eg a first switch feature and a second switch feature. The switch feature may be arranged to cooperate with the ratchet. The switch features may be radially aligned (eg, angularly offset by 180°) or may be oriented in a different radial direction (eg, offset by an angle other than 180°). The switch feature may be arranged to cooperate with the ratchet at different positions along the ratchet. That is, the locations where the two switch features engage the ratchet can be angularly separated from each other, in particular by pairs of ratchet teeth and ratchet recesses between these two locations. At least one of the first switch feature and the second switch feature may be displaced relative to the first member and/or the second member when the first member is rotated relative to the second member. Preferably, both switching features are displaced. Both switch features can be displaced in the same direction or in different directions during rotation. For example, two switch features may be displaced inwardly (eg, radially). The switch features may be shifted towards each other, eg such that the distance (eg radial distance) between two switch features decreases. Instead of being displaced in the same direction, one switch feature could be displaced outwards and the other inwards.

Having multiple switch features cooperating with the same ratchet at different positions has the advantage that the relative movement of the switch features relative to each other can be adjusted by selecting the type of engagement with the ratchet. The two switch characteristics can be in phase with respect to the ratchet. That is, in a given stable rotational or angular position of the first member relative to the second member, both switch features engage the ratchet recess or they both engage the ratchet teeth. This has the advantage that two teeth can contribute to the radial displacement and the height of the teeth can be reduced to achieve a particularly desired relative radial displacement of the switch features. Alternatively, the two switch features may be out of phase with respect to the ratchet. That is, in a given stable rotational or angular position of the first member relative to the second member, one of the switch features engages the ratchet teeth and the other engages the ratchet recess.

In one embodiment, a deformable switch feature engages the ratchet at different positions. A deformable switch feature can engage a radial ratchet. Rotation of the first member relative to the second member may axially displace a portion of the deformable switch feature, eg, due to the switch feature cooperating with ratchet teeth of the ratchet. Axial displacement of the portion may be directed proximally. The axial displacement of the part may be relative to the ratchet. Axial shifts can be used to trigger generation of usage signals. In particular, upon axial displacement, said portion may protrude from the ratchet. The switch feature may be elastically deformable such that when elastically deformed, the switch feature tends to return to its original shape due to elastic restoring forces. The switch feature may bridge the free space within the member where the ratchet is engaged by the switch feature. Switching features can be continuous. The deformable switch feature, in particular its opposite end, may engage with the ratchet recess of the ratchet before commencing a dose setting operation or a dose delivery operation. Engagement with the ratchet teeth tends to deform (eg, compress) the switch feature as the first member rotates relative to the second member. This can result in axial displacement of a portion (eg, central portion) of the switch feature. The switch feature may be configured as a fork or toggle mechanism component. The portion of the switch feature is axially displaceable in a direction away from the ratchet.

In one embodiment, the switch feature is rotationally locked to the one of the first and second members that is not provided with a ratchet.

In one embodiment, the electronic system or drug delivery device comprises a motion sensing unit. The motion sensing unit may be an electronic unit. The motion sensing unit may be a photoelectric unit. The motion sensing unit may be configured to measure and/or quantify movement of the first member relative to the second member. The encoder component is movable relative to the motion sensing unit (eg, an encoder ring). The encoder component may be or may be connected to the first member or the second member, preferably the first member. The encoder component may be a use signal generating interface component. The encoder component may comprise circumferentially spaced detection zones which, when moved into a detection position relative to the unit, trigger signal generation in the motion sensing unit. The motion sensing unit may comprise at least one sensor, preferably a plurality of sensors. Corresponding sensors can be non-contact. For example, corresponding sensors may be radiation detectors. The motion sensing unit may include an electromagnetic radiation emitter (eg, LED) and a radiation detector. The radiation emitter may emit radiation towards the encoder component, and the radiation detector may be arranged and configured to detect radiation reflected from the encoder component. In the first state, the motion sensing unit may be inoperable or switched off. In the second state of the electronic system, the motion sensing unit may be operable or switched on. Motion sensing units used for measuring relative movement of members, such as for determining a currently set or dispensed dose during a dispensing operation, may have particularly high power consumption. The currently set dose or currently dispensed dose may depend on the amount of relative movement (eg rotation) between the first member and the second member since the start of the respective operation. In the present disclosure, the motion sensing unit may only be activated after the corresponding operation on which the motion sensing unit should operate, eg a dose delivery operation and/or a dose setting operation, has started. The electronic system preferably takes into account the offset between the start or start of the dose setting operation or the dose delivery operation and the operability of the motion sensing unit, e.g. by adding a value (e.g. a constant value, such as a unit setting increments or two unit setting increments). The electronic control unit may be configured to issue commands to make the motion sensing unit operable in response to the use signal.

In one embodiment, the switch feature is configured to move a first electrical contact feature of the electrical switch into electrical and/or mechanical contact with a second electrical contact feature of the electrical switch when the first member is rotated relative to the second member . A use signal may be generated when the first electrical contact feature is in contact with the second electrical contact feature. The switch feature may be arranged to displace the second electrical contact feature during rotation of the first member relative to the second member. The switch feature may displace both the first contact feature and the second contact feature during rotation, in particular in the same direction. In this way, it can be achieved that a usage signal is generated under all tolerance conditions, because after contact has been established, the two contact features move together.

In one embodiment, the electronic system or drug delivery device includes a coupling interface (eg, an adapter) that selectively rotationally locks the first member and the second member. The coupling interface can rotationally lock the two components when established and can allow relative rotational movement when released. During a dose setting operation, a coupling interface may be established. During dose delivery operation, the coupling interface can be released.

In one embodiment, to switch from a dose setting configuration of the dose setting and drive mechanism in which dose setting operations can be performed to a dose delivery configuration of the dose setting and drive mechanism in which dose delivery operations can be performed, the first The first member and the second member may be axially displaceable relative to each other. The axial displacement may be a displacement of the second member in a distal direction relative to the first member. During the relative axial displacement, the state of the coupling interface may be switched, for example from established to released, or vice versa. The relative axial displacement changing the state of the coupling interface may be mandatory before the dose delivery operation can start. Relative axial displacement may be performed by movement of a user interface member of the device or system, which may be connected to one of the first and second members or connected to one of these members (e.g., dose or injection button) into one. Axial displacement may be achieved when the user depresses a surface on the button, for example in a distal direction. In other words, the first member and the second member may have different axial positions relative to each other in a dose setting operation and in a dose delivery operation.

In one embodiment, the ratchet (eg, in the use signal generating interface member) is designed to allow relative rotation between the first member and the second member in two opposite directions or in only one direction. In other words, ratchets can be one-way or two-way. Where a one-way ratchet is provided, the ratchet may provide resistance or prevent movement of the first member relative to the second member when in the dose delivery configuration (e.g. when the second member has been axially displaced relative to the first member) The resistance to rotation in the direction of the set dose will be increased.

In one embodiment, the use signal is generated independently of changes in the axial position of the user interface member or the second member relative to the first member. That is, merely pressing the user interface member does not result in a usage signal being generated. Instead, rotational movement of the first member relative to the second member is required to generate the use signal.

The relative relationship or position between the switch feature and the ratchet (eg, using the ratchet in the signal generating interface member) may be different and/or varied in the dose setting configuration and/or in the dose delivery configuration.

For example, the switch feature may only engage the ratchet during an initial phase of a dose setting operation or a dose delivery operation, in particular before relative axial movement between the first and second members is complete. In this way, after the use signal has been generated, the switch feature can be disengaged from the ratchet and eg engage the planar surface with correspondingly less frictional losses, which can result in less torque or force required to operate the device. Thus, the switch feature may engage the ratchet and may disengage said ratchet after an initial relative rotation has been completed to generate the use signal (eg after a dose delivery operation has commenced). After an operation (eg a dose delivery operation) has been completed, the switch feature may be re-engaged with the ratchet, eg by a spring. The spring may be a coupling spring that re-establishes the adapter interface between the first member and the second member.

In one embodiment, the power consumption, in particular the maximum power consumption, in the first state (eg, before generating the use signal) may be less than or equal to one of the following values: 300nA, 250nA, 200nA (nA: nanoamperes) . Alternatively or additionally, in the second state, the power consumption, in particular the minimum power consumption, may be greater than or equal to one of the following values: 0.5mA, 0.6mA, 0.8mA (mA: milliampere). The difference may be caused by the power consumption of the motion sensing unit and/or the communication unit which may be active or operable in the second state of the electronic system and in the first state of the electronic system. One state is off or in sleep state.

In one embodiment, the motion sensing unit may be operable when active (eg, in the second state of the system) to collect motion data or measurement data related to the relative movement of the first member and the second member. The electronic control unit may be configured to convert such data into dose data, for example an indication of the dose size that has been set or delivered in the respective operation. Dosage data can be calculated from measurement data. The communication unit may be configured to transmit dose data to an external unit, eg a mobile phone, tablet or personal computer.

In one embodiment, the amount or distance of relative movement between the first member and the second member is indicative of a currently set dose in a dose setting operation or a currently dispensed dose in a dose delivery operation. The size of the delivered dose may be determined by or correspond to the distance by which the piston rod of the drive mechanism is displaced distally relative to the housing during a dose delivery operation by the dose setting and/or said distance.

In one embodiment, the power consumption P2 in the second state may be greater than or equal to at least one of the following values: 2*P1, 3*P1, 4*P1, 5*P1, 10*P1, 20*P1, 30*P1, 40*P1, 50*P1, 100*P1, 500*P1, 1000*P1, 2000*P1, 5000*P1, 10000*P1, where P1 is the power consumption in the first state. In the second state, the motion sensing unit may be active and/or a communication unit (eg, for wireless communication).

In one embodiment, the electronic system may be configured such that it is switched back to the first, lower power consumption state after a predetermined time has elapsed.

In one embodiment, the drug delivery device comprises a reservoir with drug or a reservoir holder configured to receive the reservoir with drug. The medicine can be a liquid medicine. The reservoir may contain an amount of drug sufficient to deliver multiple doses. The reservoir may contain an amount of drug sufficient to deliver a plurality of maximum settable doses. The reservoir may be a cartridge. The device may be a device for self-administration by a user (eg, a medically trained or untrained user such as a patient). The device may be a pen-type device. The device may be a needle-based device or may be needle-free. The drug delivery device may be a reusable device and/or the electronic system may be a reusable electronic system. In particular, the electronic system is preferably designed for use with multiple disposable drug delivery devices or in reusable drug delivery devices where one or more replacement reservoirs are provided once the reservoir has been emptied. . The drug delivery device may be a body worn or portable device. Thus, the device may be a device that is carried by a user to a possibly remote location, and thus the device may not be configured to be connected to a power source.

It should be noted that features disclosed above and below in connection with different embodiments and/or aspects may be combined with each other and also with other features of other aspects or embodiments.

In a particularly advantageous embodiment, there is provided an electronic system for a drug delivery device comprising:

- a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose ,

The dose setting and drive mechanism comprises a first member and a second member, wherein the dose setting and drive mechanism is configured such that, in a dose delivery operation and/or in a dose setting operation, the first member is relatively movement (for example, rotation and/or axial movement);

- An electronic control unit configured to control the operation of an electronic system having a first state and a second state, wherein the electronic system has a power consumption in the second state compared to the first state increased;

- an electricity usage detection unit operatively connected to the electronic control unit, the electricity usage detection unit being configured to generate a usage signal indicating that the user has initiated a dose setting operation or a dose delivery operation, wherein

The electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the usage signal, and wherein

The electrical usage detection unit is configured to generate a usage signal in response to relative movement (eg relative rotational movement) between the first member and the second member, preferably during a dose delivery operation.

Further aspects, embodiments and advantages will become apparent from the following description of exemplary embodiments taken in conjunction with the accompanying drawings.

Description of drawings

Figure 1 shows an embodiment of a drug delivery device.

Figure 2 shows the proximal end of a drug delivery device according to another embodiment.

Figure 3A shows the proximal end of the injection device of Figure 2 after actuation of the injection button.

Figure 3B shows a cross-sectional view of the injection device of Figure 2 after actuation of the injection button.

FIG. 4 is an enlarged cross-sectional view of the device of FIG. 2 .

Figure 5 is an elevational side view of a first type of encoder system.

FIG. 6 is a plan view of the encoder system shown in FIG. 5 .

Fig. 7 is a schematic block diagram of a device controller.

Figure 8A is a cross-sectional view of the proximal end of the device prior to actuation of the injection button.

8B is a cross-sectional view of the proximal end of the device during partial actuation of the injection button.

Figure 8C is a cross-sectional view of the proximal end of the device during full actuation of the injection button.

Figure 9 is an elevational side view of a second type of encoder system.

FIG. 10 is a plan view of the encoder system shown in FIG. 9 .

Figure 11 shows the Gray code output.

Figure 12 is a partial plan view of the encoder system.

Figure 13 is a partial plan view of the encoder system.

Figure 14 is an elevational side view of a third type of encoder system.

Figure 15A is a partial plan view of the encoder system.

Figure 15B is a partial plan view of the encoder system.

Figure 16 is an elevational side view of a fourth type of encoder system.

Figure 17 is an elevational side view of a fifth type of encoder system.

Fig. 18A is a plan view of a sixth type of encoder system.

Fig. 18B is a plan view of a seventh type of encoder system.

Figure 19A is a screenshot showing oscilloscope traces obtained from various embodiments.

Figure 19B is a close-up view of the screenshot of Figure 19A.

Figure 20 schematically illustrates an embodiment of an electronic system for a drug delivery device.

Figure 21 illustrates an embodiment of an electronic system and in particular its usage detection unit for generating a usage signal.

Figure 22 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 23 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 24 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

25A and 25B illustrate another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figures 26A and 26B illustrate another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 27 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 28 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 29 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

Figure 30 illustrates another embodiment of the electronic system and in particular its usage detection unit for generating a usage signal.

31A-31E illustrate an embodiment of an electronic system and in particular its usage detection unit for generating a usage signal.

Detailed ways

In the figures, identical elements, identically acting elements, or elements of the same kind may be provided with the same reference signs.

In the following, some embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and may equally well be deployed with injection devices configured to eject other medicaments or drug delivery devices in general (preferably pen devices and/or injection devices).

Embodiments are provided in relation to injection devices, in particular in relation to variable dose injection devices, which record and/or track data regarding doses delivered thereby. These data can include the size of the dose selected and/or the size of the dose actually delivered, the time and date of administration, the duration of administration, and the like. Features described herein include placement of sensing elements and power management techniques (eg, to facilitate small batteries and/or achieve efficient power usage).

注射装置说明了本文献中的某些实施方案。注射按钮可以提供用于启动和/或执行药物递送装置的剂量递送操作的用户接口构件。握把或旋钮可以提供用于启动和/或执行剂量设定操作的用户接口构件。两个装置均为拨选延伸类型，即，它们的长度在剂量设定期间增加。在剂量设定和剂量排出操作模式期间，具有拨选延伸部和按钮的相同运动学行为的其他注射装置已知为例如由Eli Lilly出售的

或

装置和由NovoNordisk出售的

或

装置。因此，将一般原理应用于这些装置显得简单明了，并且将省略进一步的解释。然而，本公开文本的一般原理不限于所述运动学行为。可以设想某些其他实施方案以应用于Sanofi的

注射装置，其中存在单独的注射按钮和握把部件/剂量设定构件。因此，可以存在两个单独的用户接口构件：一个用于剂量设定操作；并且一个用于剂量递送操作。Regarding Sanofi's in which the injection button and the grip (dose setting member or dose setter) are combined

Injection devices illustrate certain embodiments in this document. The injection button may provide a user interface member for initiating and/or performing a dose delivery operation of the drug delivery device. The grip or knob may provide a user interface member for initiating and/or performing dose setting operations. Both devices are of the dial extension type, ie their length increases during dose setting. Other injection devices with the same kinematic behavior of the dial extension and button during the dose setting and dose expelling modes of operation are known, for example as sold by Eli Lilly

or

device and sold by NovoNordisk

or

device. Therefore, it appears straightforward to apply the general principles to these devices, and further explanation will be omitted. However, the general principles of the present disclosure are not limited to the kinematic behavior described. Certain other implementations can be envisaged for application to Sanofi's

An injection device in which there are separate injection button and handle parts/dose setting members. Thus, there may be two separate user interface members: one for dose setting operations; and one for dose delivery operations.

"Distal" is used herein to designate a direction that is or is to be arranged facing or pointing towards the dispensing end of the drug delivery device or a component thereof and/or points outwards, is to be arranged facing or facing away from the proximal end , an end, or a surface. On the other hand, "proximal" is used to designate a direction, an end or a surface which is or is to be arranged facing or facing away from the dispensing end and/or the distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dispensing end and/or furthest from the proximal end, and the proximal end may be the end furthest from the dispensing end. The proximal surface can face away from the distal end and/or face proximally. The distal surface can face distally and/or away from proximally. For example, the dispensing end may be the needle end to which the needle unit is mounted or to be mounted to the device.

Figure 1 is an exploded view of a drug delivery device or drug delivery device. In this example, the drug delivery device is an injection device 1 , eg a pen-type injector.

The injection device 1 of Fig. 1 is an injection pen comprising a housing 10 and containing eg a container 14 (eg an insulin container) or a receptacle for such a container. The container can contain a drug. Needle 15 may be attached to a container or receptacle. The container may be a cartridge and the receptacle may be a cartridge holder. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or another cap 18 . The dose of insulin to be expelled from the injection device 1 can be set, preset or "dial-in" by turning the dose knob 12 and then displaying (eg in multiples of the unit) the currently preset or set dose via the dose window 13 dose. The indicia displayed in the window can be provided on the number sleeve or the dial sleeve. For example, where the injection device 1 is configured to administer human insulin, the dosage may be expressed in so-called International Units (IU), where one IU is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in the injection device for delivery of insulin analogs or other pharmaceutical agents. It should be noted that the selected dose can equally well be displayed in a different way than shown in the dose window 13 in FIG. 1 .

The dose window 13 may be in the form of an aperture in the housing 10 which allows the user to view a limited portion of the dial sleeve 70 which is configured to move when the dose knob 12 is turned to provide the currently programmed dose. visual indication. When turned during programming, dose knob 12 rotates in a helical path relative to housing 10 .

In this example, the dose knob 12 includes one or more formations 71a, 71b, 71c to facilitate attachment of a data collection device.

The injection device 1 may be configured such that turning the dose knob 12 causes a mechanical click to provide acoustic feedback to the user. In this embodiment the dose knob or button 12 also serves as the injection button 11 . When the needle 15 is pierced into the patient's skin part, and then the dose knob 12/injection button 11 is pushed in the axial direction, the insulin dose displayed in the display window 13 will be ejected from the injection device 1 . A dose is injected into the patient when the needle 15 of the injection device 1 remains in the skin part for a certain time after pushing the dose knob 12 to the correct position. The ejection of an insulin dose may also cause a mechanical click, however this is different from the sound produced when the dose knob 12 is turned during dialing of a dose.

In this embodiment, during the delivery of an insulin dose, the dose knob 12 returns in axial movement to its original position (without rotation), while the dial sleeve 70 rotates back to its original position, e.g. showing a dose of zero units . As already indicated, the present disclosure is not limited to insulin, but should cover all drugs in the drug container 14, especially liquid drugs or drug preparations.

The injection device 1 can be used for several injection procedures until the insulin container 14 is empty or the medicament in the injection device 1 reaches an expiration date (eg 28 days after first use).

Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "preparation injection" to ensure that the fluid is flowing correctly from the insulin container 14 and the needle 15, for example by selecting two units of insulin and holding the injection device 1 on the needle 15. Do this by pressing the dose knob 12 upwards. For the sake of presentation, in the following it will be assumed that the ejected amount substantially corresponds to the injected dose, so that eg the amount of medicine ejected from the injection device 1 is equal to the dose received by the user.

As explained above, the dose knob 12 also serves as the injection button 11, so that the same part is used for dialing/setting the dose and dispensing/delivering the dose.

Figures 2, 3A and 3B show the proximal end of a device 2 according to a second embodiment. The device 2 includes a handle 205 and an injection button 210 . Unlike the device 1 shown in Figure 1, the injection button 210 is separate from the handle 205 which is used to dial the dose. Dial sleeve 70 and injection button 210 are located partially inside handle 205 . The grip 205 and the dial sleeve 70 can be considered functionally as elements of the same part. In practice, the grip 205 and dial sleeve 70 could only be separate parts for assembly reasons. Apart from the differences described herein, the device 2 shown in Figure 2 operates in substantially the same way as the device 1 shown in Figure 1 .

Similar to device 1 , dial sleeve 70 , handle 205 and injection button 210 extend helically from device 2 . During the dose dial mode of operation (as shown in FIG. 2 ), there is no relative rotation between the injection button 210 and the dial sleeve 70 . The dose is dialed by rotating the handle 205 (and thus also the dial sleeve 70 and injection button 210 ) relative to the rest of the device 2 .

To initiate the dispensing of the medicament, the injection button 210 is pressed axially as shown in Figures 3A and 3B. This action changes the mode of the device 2 to dispense mode. In dispense mode, the dial sleeve 70 and handle member 205 are retracted along a helical path into the rest of the device 2, while the injection button 210 does not rotate and is retracted only with an axial movement. Thus, in the dispense mode, the injection button 210 is disengaged, resulting in relative rotation of the injection button 210 relative to the dial sleeve 70 . This disengagement of the injection button 210 relative to the dial sleeve 70 is caused by the adapter arrangement or interface described in more detail in connection with FIGS. 8A-8C .

Figure 4 is a close-up cross-sectional view of the proximal end of the device 2 shown in Figure 3 after the injection button 210 has been pressed. As shown in Figure 4, the injection button 210 is configured as two separate sub-components, namely a distal or lower button portion 210a and a proximal or upper button portion 210b. Injection button 210 may be configured in this manner to aid in the assembly process. Distal button portion 210a and proximal button portion 210b may be secured together and functionally function as a single component, ie, injection button 210 .

A sensor arrangement 215 comprising one or more sensors is mounted in the injection button 210 , the sensor arrangement being configured to sense the relative rotational position of the dial sleeve 70 relative to the injection button 210 . This relative rotation may equate to the dispensed dose size and serve the purpose of generating and storing or displaying dose history information. The sensor arrangement 215 may include a primary sensor 215a and a secondary sensor 215b. In Fig. 4, only the secondary sensor 215b is shown. In the following discussion, these sensors are optical sensors, however, a number of alternative options are equally applicable to various embodiments, such as photoelectric sensors, inductive sensors, capacitive sensors, contact sensors, non-contact sensors, magnetic sensors, and the like.

5 and 6 illustrate an encoder system 500 according to certain embodiments. The encoder system is configured for use with the device 2 described above. As shown in FIGS. 5 and 6 , primary sensor 215 a and secondary sensor 215 b are configured for a specially adapted area at the proximal end of dial sleeve 70 . In this embodiment, primary sensor 215a and secondary sensor 215b are infrared (IR) reflective sensors. Accordingly, the specially adapted proximal region of the dial sleeve 70 is divided into a reflective zone 70a and a non-reflective (or absorptive) zone 70b. The portion of dial sleeve 70 including reflective region 70a and non-reflective (or absorptive) region 70b may be referred to as an encoder ring.

In order to keep production costs at a minimum, it may be advantageous to form these regions 70a, 70b from an injection molded polymer. In the case of polymeric materials, the absorptivity and reflectivity can be controlled with additives such as carbon black for absorptivity and titanium dioxide for reflectivity. Alternative implementations are possible in which the absorptive area is a shaped polymer material and the reflective area is made of metal (additional metal components, or selective metallization of segments of the polymer dial sleeve 70) .

Having two sensors facilitates the power management techniques described below. The primary sensor 215a is arranged for a series of alternating reflective regions 70a and non-reflective regions 70b at a frequency corresponding to the required resolution (eg, 1 IU) for the dosage history requirements applicable to a particular drug or dosing regimen. The secondary sensor 215b is arranged for a series of alternating reflective regions 70a and non-reflective regions 70b at a reduced frequency compared to the primary sensor 215a. It should be understood that the encoder system 500 may only work with the primary sensor 215a to measure the dose dispensed. The secondary sensor 215b facilitates the power management techniques described below.

In Figures 5 and 6 two sets of coding regions 70a, 70b are shown which are concentric with one outer region and another inner region. However, any suitable arrangement of the two coding regions 70a, 70b is possible. Although the regions 70a, 70b are shown as castellated regions, it should be kept in mind that other shapes and configurations are possible.

The apparatus 1, 2 also includes a controller 700, as schematically shown in FIG. 7 . The controller 700 includes a processor arrangement 23 comprising one or more processors, for example, microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) ) etc.; and a memory unit 24, 25 comprising a program memory 25 and a main memory 24 which may store software executed by the processor arrangement 23.

The controller 700 controls the sensor arrangement 215 comprising one or more sensors 215a, 215b.

)与另一个装置通信的无线通信接口；或用于有线通信链路的接口，诸如用于接纳通用串行总线(USB)、迷你USB或微型USB连接器的插座。例如，可以将数据输出到附接到装置1、2的数据收集装置。An output 27 is provided which may be for use via a wireless network such as Wi-Fi or

) a wireless communication interface to communicate with another device; or an interface for a wired communication link, such as a receptacle for receiving a Universal Serial Bus (USB), mini-USB or micro-USB connector. For example, the data may be output to a data collection device attached to the device 1 , 2 .

A power switch 28 and a battery 29 as a power source are also provided.

It is advantageous to be able to minimize the power usage of the encoder system 500 so that the size of the battery 29 that needs to be packaged into the device 1 , 2 can be minimized. The sensors 215a, 215b used in this embodiment require a certain amount of power to operate. This embodiment is arranged so that the sensors 215a, 215b can be switched on and off intermittently at a controlled frequency (ie in a gated sampling mode). There is an inherent limit on the maximum rotational speed that can be counted by a sampled encoder system before aliasing occurs. Aliasing is the phenomenon where the sampling rate is less than the rate at which the area being sensed passes the sensor, meaning that count errors can occur when area changes are missed. The reduced frequency secondary sensor 215b compared to the primary frequency 215a can tolerate higher rotational speeds before it also becomes aliased. Although the secondary sensor 215b cannot resolve the dose dispensed with the same resolution as the primary sensor 215a, the output of the secondary sensor 215b remains reliable at higher speeds. Thus, the two sensors 215a, 215b are used in combination to enable an accurate determination of the delivered dose up to the first threshold rotational speed (dispensing speed). The sensors 215a, 215b may then be used to determine the approximate dose delivered until a second (higher) threshold dosing rate. At speeds above the second threshold speed, the sensors 215a, 215b will not be able to accurately or approximately determine the delivered dose, so the second threshold is set higher than the physical speed when fluid is ejected from the injection device 1, 2. impossible speed.

The first velocity threshold is determined by the sampling rate of the primary sensor 215a and the frequency of encoder zone transitions, which is fixed at the resolution required for the desired drug or dosing regimen (eg, transitions every 1 IU). The second speed threshold is determined by the sampling rate of the secondary sensor 215b and the frequency of encoder zone transitions. The first threshold is set such that the system can cover the maximum dispensing speed range to accurately report dispensed doses.

The exemplary embodiment shown in FIG. 6 has a primary sensor 215a switching for zone switching at 1 switch per 1 IU dose delivered and a secondary sensor 215b switching for zone switching at 1 switch per 6 IU dose delivered. Other options are possible including 1 conversion every 2 IU, 1 conversion every 4 IU, 1 conversion every 8 IU, and 1 conversion per IU unit. Each of these options is possible because in the encoder system 500 shown in Figure 6, there are 24 individual regions 70a, 70b per revolution. In general, if the number of individual regions 70a, 70b per revolution is n units, there is an option to switch every m units, where m is any integer factor greater than 1 and less than n.

The slower the sampling frequency of the two sensors 215a, 215b, the lower the required power consumption and therefore the smaller the size of the battery 29 required. Therefore, in practical situations, it is optimal to minimize the sampling frequency by design.

To further limit battery capacity requirements, it is advantageous to be able to place the device 2 in a low power state when power to the sensors 215a, 215b is not required. This may be accomplished by a switch activated by displacement of the injection button 210 .

As shown in FIG. 8A , a switch 800 is installed in the injection button 210 . In the configuration shown in FIG. 8A, the arm of switch 800 is deflected by dial sleeve 70 such that switch 800 is in the off state. In this configuration, the adapter between the adapter part and the dial sleeve 70 is engaged with the device 2 in its dial mode. When the injection button 210 is depressed, the injection button 210 is axially displaced relative to the dial sleeve 70 and thus the switch 800 is axially displaced relative to the dial sleeve 70 . This displacement causes a portion on dial sleeve 70 to descend along the cam surface on switch 800, allowing the switch arm to deflect toward its free state. This deflection in the switch arm has the effect of changing the electrical state of switch 800 (eg, becoming electrically closed). The design is arranged such that the change of electrical state of switch 800 occurs before the change of state of the adapter between the adapter member and dial sleeve 70 . Figure 8B shows the transition point of the adapter and shows that the switch 800 has changed state. Figure 8C shows the state of the device 2 when the injection button 210 is fully depressed. In this case, the adapter is completely disengaged, allowing the adapter part and dial sleeve 70 to rotate relative to each other in the dispensing mode.

This sequence operates in reverse when the injection button 210 is released.

The electrical state change occurs when the injection button 210 is depressed, thereby allowing the device 2 to be switched off into a low power state if the injection button 210 is not depressed. In this state, relative rotation between the injection button 210 and the dial sleeve 70 is not possible, so the encoder system 500 is not required.

The mechanical configuration between dial sleeve 70 and switch 800 may operate in the opposite direction such that the arm of switch 800 is deflected during dispensing rather than during dialing.

The following embodiments relate to an alternative sensing technique to determine the number of dosage units that have been dispensed from the device 1 , 2 .

As with the embodiments described above, two sensors 215 are mounted in the injection button 210 and are configured to sense the relative rotational position of the dial sleeve 70 with respect to the injection button 210 during dose dispensing. This relative rotation may equate to the dispensed dose size and serve the purpose of generating and storing or displaying dose history information.

As shown in FIG. 9 , the two sensors 215 from this embodiment are configured for specially adapted regions 70 a , 70 b of the dial sleeve 70 . In this embodiment, an IR reflective sensor is used, so the area of the dial sleeve 70 is divided into a reflective section 70a and an absorptive section 70b. Sections 70a, 70b may also be referred to herein as markers or detection regions.

Unlike the encoder system 500 described above with respect to Figures 5 and 6, the encoder system 900 shown in Figures 9 and 10 has two IR sensors 215, for the same type of zones 70a, 70b. In other words, the sensors 215 are arranged such that they face the reflective area 70a and the absorptive area 70b on the same surface. The sensors 215 may be arranged such that one sensor faces the reflective region 70a and one sensor faces the absorptive region at the same time. During dose dispensing, the dial sleeve 70 is rotated 15° counterclockwise relative to the injection button 210 for each dose unit that has been dispensed. Alternative logo elements are located in 30° (or two units) sections. The sensors 215 are arranged out of phase with each other such that the angle between them is equal to an odd number of units (eg, 15°, 45°, 75°, etc.), as shown in FIG. 10 .

The encoder system 900 shown in Fig. 10 has 12 segments per revolution, ie 12 alternating regions 70a, 70b. Typically, implementations operate at any multiple of 4 units per revolution. The angle a between the sensors 215 can be expressed by Equation 1, where m and n are any integers and 4m units are allocated per revolution.

Equation 1 - Angle between sensors

Figure 11 shows how the output of sensor A and sensor B changes when dial sleeve 70 is rotated counterclockwise during medicament dispensing.

The combination of two sensors A, B produces a 2-bit Gray code output (11, 01, 00, 10). The 2-digit code sequence repeats every four allocated units. This encoded output facilitates detection of positive (counterclockwise) and negative (clockwise) rotation. For example, when the sensor reads "11", changing to "01" will result in a positive rotation, while changing to "10" will result in a negative rotation. Such direction sensitive systems are superior to purely incremental systems in their ability to accurately determine the true dispensed dose volume where negative rotation may occur. For example, when the user releases the injection button 210, the over-rotating mechanism stops before "backing out" at the end of the dose.

Referring to FIG. 12, the IR sensor 215 emits IR light from the LED. The IR reflective region 70a of the encoder system 900 reflects light, and a sensor detects the reflected light. The sensor 215 then converts the detected light into an electrical output. The intensity of the IR light detected by sensor 215 after reflection from the encoder ring is proportional to the proximity of the sensor and encoder ring. Therefore, it is desirable for the sensor 215 to be as radially close to the encoder ring as possible without contacting the encoder ring, which would increase the friction losses of the dispensing mechanism.

Referring to FIG. 13 , the IR absorptive region 70 b of the dial sleeve 70 does not completely absorb all of the IR light emitted from the sensor 215 . Testing has shown that when the sensor 215 is aligned with the absorptive region 70b of the dial sleeve 70, the sensor 215 has some electrical output due to the lower level of IR light reflected by the dial sleeve 70. Accordingly, the dial sleeve markers are designed to maximize the distance between the sensor 215 and any intentionally IR absorbing portion of the encoder ring. This ensures high contrast and signal clarity.

The software of the device 1, 2 monitors the electrical output of the sensor 215 as the dose is dispensed. The software detects the change between high and low output to determine when the relative rotation between dial sleeve 70 and injection button 210 has reached an additional 15° (ie, another unit has been dispensed). Therefore, it is beneficial for the function of the device to have as large a contrast as possible between high output and low output.

According to various embodiments, the design of the dial sleeve 70 and encoder ring logos 70a, 70b have been developed to increase contrast. The design shown in Figure 14 removes the absorbent dial sleeve marker 70b to leave a gap 140 between adjacent encoder ring markers 70a. This maximizes the distance between the sensor 215 and any material that may reflect any IR light emitted from the sensor.

This design increases the contrast between low and high sensor electrical outputs. However, as shown in FIG. 15A, the infrared light emitted by sensor 215 is not a beam, so that when dial sleeve 70 is rotated between reflective encoder ring mark 70a and gap 140, sensor 215 detects the infrared light emitted by sensor 215. There is overlap at the positions of some lights. During this period, the sensor output tapers off from high to low rather than an immediate step change between high and low. This gradual decrease is more difficult than an immediate step change for what the software determines is a 15° rotation (ie, one dose unit dispensed).

This phenomenon occurs in various embodiments of encoder markers (as shown in Figures 9 and 14). However, as shown in FIG. 15B , according to certain embodiments, due to the visibility of the side of the reflective encoder ring marker 70a, the rotation required for the dial sleeve 70 before the sensor output fully switches to low output is increased.

Therefore, it is advantageous to reduce the thickness of the IR reflective markers 70a on the encoder ring at the edges. Figures 16 and 17 show two possible implementations that reduce the thickness at the side edges of the IR reflective markers 70a on the encoder ring such that the reflective surfaces slope inwards to prevent or reduce diffuse reflections, thereby Enhanced contrast conversion and signal clarity.

FIG. 16 shows an embodiment in which the formed polymeric encoder ring has been replaced by a formed metal ring 160 .

Figure 17 shows where the molded polymer encoder ring has been replaced by a portion of the dial sleeve 70 that is printed, painted or coated with an IR reflective material.

18A and 18B illustrate two alternative modes of operation according to various embodiments. Referring to Figure 18A, Sensor I and Sensor II are provided with an angular offset (δ) that is half the periodicity (φ) of the encoding region of the encoder ring. In this embodiment, the sensors are operated to sample synchronously (ie, at the same time (t ₁ , t ₂ , t ₃ , . . . )).

Figure 18A illustrates an embodiment where the angular offset (δ) is different from half of the characteristic periodicity (φ/2) and the sensors are operated in a staggered fashion with a time offset (Δt) between samples. This can be used to achieve a more balanced overall system LED power consumption than would be available in synchronous operation.

In the configuration shown in Figure 18B, the amount of angular offset (δ) can be reduced to less than half of the characteristic periodicity (φ) in order to compensate for the time offset (Δt) between sampling operations of different sensors Relative angular travel during.

The time offset (Δt) can be adjusted based on an estimate of the relative rotational speed (ω) of the encoder ring, which can be calculated from sensor measurements. Specifically, when it is determined that the rotational speed (ω) increases, the offset time (Δt) may decrease.

Figure 19A shows an oscilloscope trace obtained by an embodiment of the present disclosure. The lower trace is the LED drive signal, while the upper trace is the output of the current mirror before the Schmitt trigger.

Figure 19B is an enlarged view of the oscilloscope trace shown in Figure 19A. It turns out that it is possible to sample at 256µs with a duty cycle close to 12 to 1 (meaning that the average current is 1/12 that of a 4mA LED driver, thus saving power and battery capacity. This equates to a sampling rate of over 3900Hz, And with one unit per segment and at least two samples per segment, detection speeds in excess of 1950 units per second are achieved without violating the Nyquist criterion. Thus, no anti-aliasing is required stack detector.

While the above embodiments have been described with respect to acquiring data from an insulin syringe pen, it should be noted that embodiments of the present disclosure may be used for other purposes, such as monitoring injections of other medicaments or drug delivery devices in general, for example.

As already discussed above, managing the power consumption or resources of a power source (e.g., a rechargeable or non-rechargeable battery 29) in a drug delivery device that includes an electronic system, such as the injection device discussed further above, is an issue that needs to be addressed. Problems, for example in order to optimize the use of the capacity of the power supply and/or to take into account the sometimes considerable inventory time of the drug delivery device before the device reaches the user or patient. There is a need to ensure that devices including electronic systems continue to function properly for the duration of their intended use.

The present disclosure presents various concepts that may be implemented in a drug delivery device or its electronic system or thus used eg to improve power management in the device. Some concepts rely on providing power to certain elements of the device only when needed or when there is a high probability that power will be needed. The devices already discussed above eg activate the motion sensing unit (sensor system) of the device only when the injection button (as user interface member) is being pressed to perform a dose delivery (injection) operation. After the motion sensing unit has been actuated, the encoder member or encoder ring may be used to collect data about the movement indicative of the dose that has been delivered during the delivery operation. From the measured movement data, it is possible to calculate how much drug has actually been delivered. For example, when the user interrupts the delivery operation before the delivery operation has actually been completed, the actual delivered drug amount does not necessarily coincide with the dose previously set in the dose setting operation. It is therefore advantageous to measure movements occurring during a dose delivery operation, which movements are related to the amount of drug that has been delivered, for example in order to know the current status or progress of the delivery operation. The determined delivered dose may preferably be communicated wirelessly to an external or remote device, eg a handheld device such as a smartphone. In this way, a dose log can be established regarding the doses delivered by the user, which can be easily accessed by the user.

The proposed concept is applicable to a wide variety of drug delivery devices including electronic systems or to electronic systems for such devices and not only for the devices described further above. The device may be an injection device and/or a pen-type device. The device may be configured to receive or include a medicament container or cartridge. The container or cartridge may be filled with liquid drug to be delivered by the device. The device can be designed to deliver multiple doses of drug. Thus, the container or cartridge may contain an amount of drug sufficient to deliver several doses by the device. The device may be reusable or disposable, wherein a reusable device may be provided with a replacement medicament container or cartridge when the current container or cartridge is deemed empty or needs to be replaced for different reasons. A disposable device may be a single use device that is disposed of after the medicament container has been emptied. The device may be a dial extension type device (that is to say a device that increases in length during a dose setting operation), where the increase in length is proportional to the size of the set dose. During the associated dose delivery operation, the length of the device may be reduced again eg until the device resumes its original length (ie the length it had before the dose setting operation had started). Alternatively, the length of the device may be independent of the size of the set dose, eg, be constant or substantially constant during dose setting and/or dose delivery. The dose setting operation may involve preferably rotational movement of a dose setting member as a user interface member, eg a knob, button or grip part (as already discussed further above). The dose delivery operation may involve a preferably axial movement of a dose delivery member (eg a button such as the injection button discussed further above) as a user interface member. As already discussed further above, the dose setting member and the dose delivery member may be formed from a single (e.g. integral) part (where preferably different surfaces of the part are manipulated during the dose setting operation and the dose delivery operation), or alternatively , the dose setting member and the dose delivery member may be separate components/interface members or parts (wherein relative movement between these members is possible, for example so as to place the dose setting and drive mechanism in the dose setting configuration and the dose delivery switch between configurations). There may be relative movement between these components during dose setting or dose delivery, or both. During a dose setting operation, the lateral surface or side surface (ie the radially facing surface) of the dose setting member may be gripped by the user eg with the thumb and forefinger. During a dose delivery operation, an axially (eg proximally) facing surface of the dose delivery member may be touched by a user eg with a thumb. During a dose delivery operation, the user may transmit an axial force to the dose delivery member to initiate and/or continuously drive the dose delivery operation using the dose setting and drive mechanism of the device, which is in addition to the user interface In addition to the components, further components may be included, such as, for example, a drive member and a piston rod. The drive member may engage the piston rod. In one embodiment, the dose delivery member may be, for example, a drive member threadably engaging a piston rod. The device may be a device as disclosed in eg WO 2015/028439 A1 which is hereby incorporated by reference in its entirety.

The device may be a needle-based device (ie, the drug may be delivered into the body via a needle piercing the skin) or may be needle-free. The device may be a device with a delivery aid, eg, a spring-assisted or spring-driven device. In such devices, the user's dose delivery operation is assisted or fully powered by energy provided by an energy storage member, such as a spring. The energy in the storage member may be increased during a dose setting operation by the user, or the energy storage member may be supplied by the manufacturer with all the energy required to empty a medicament container pre-stored in the member. In the latter case, such as during a dose setting operation, the user need not provide energy to increase the energy stored in the energy storage member.

FIG. 20 illustrates the general configuration of elements of an electronic system 1000 that may be used in a drug delivery device (eg, one of the devices discussed further above or other devices).

The electronic system 1000 includes an electronic control unit 1100 . The control unit may include the controller 700 as discussed further above. In particular, the control unit may comprise a processor arrangement 23 as discussed further above. Also, control unit 1100 may include one or more memory units, such as program memory 25 and main memory 24 discussed further above in connection with FIG. 7 . The control unit 1100 is conveniently designed to control the operation of the electronic system 1000 . The control unit 1100 may communicate with another unit of the electronic system 1000 via a wired interface or a wireless interface. The control unit may transmit signals and/or data comprising commands to the units and/or may receive signals and/or data from corresponding units. The connection between the unit and the electronic control unit is indicated by the lines in FIG. 20 . However, connections not explicitly shown may also exist between the described elements. The control unit may be arranged on a conductor carrier, eg a (printed) circuit board. One or more other units of the electronic system may comprise one or more components likewise arranged on the conductor carrier.

The electronic system 1000 may further include a motion sensing unit 1200 . Motion sensing unit 1200 may include one or more sensors, such as sensors 215a and 215b described further above. In case an optoelectronic sensor detecting electromagnetic radiation, such as an IR sensor, is used, the motion sensing unit may additionally comprise a radiation emitter emitting radiation to be detected by the sensor. However, it should be noted that other sensor systems (eg magnetic sensors) may also be employed. The power consumption of a motion sensing unit having electrically operated sensors and electrically operated sources for stimulating the sensors, such as radiation emitters and associated sensors, may be relatively high in power consumption, and thus its power management may have particular implications. Each sensor may have an associated radiation emitter. The motion sensing unit 1200 may be designed to detect and preferably measure the dose setting and drive mechanism of the drug delivery device, or both movable members of the drug delivery device during a dose setting operation. and/or relative movement during dose dispensing operations. For example, the motion sensing unit may measure or detect relative rotational movement of two movable members of the dose setting and drive mechanism with respect to each other. Based on movement data received or calculated from signals from unit 1200, the control unit may calculate dosage data.

The electronic system 1000 may further include a usage detection unit 1300 . The use detection unit may be associated with the user interface member or user interface members such that manipulation of the member for setting and/or delivering a dose thereof can be detected. When a manipulation is detected, the usage detection unit generates a usage signal or triggers the generation of a usage signal. The usage signal may be transmitted to the electronic control unit 1100 . The electronic control unit may issue commands or signals to one electric operating unit, arbitrarily selected plurality of electric operating units, or all electric operating units among the other electric operating units of the system in response to the signal. For example, the control unit may cause the respective unit to switch from a first state with lower power consumption (eg sleep state or idle state) or an off state with no power consumption to a second state with increased power consumption. Said switching can be accomplished by corresponding switching commands or signals sent by the electronic control unit to the corresponding units. In response to the use signal, all cells may switch to the second state, or only selected cells may switch to the second state. If only selected units are switched to the second state with higher power consumption, it is advantageous that these units are intended to be used during an operation that the user intends to start or has already started.

For example, after generating a use signal or actuating a user interface member to initiate operation of the system (e.g., a dose delivery operation), for example, a typical time required to switch the motion sensing unit to the second state is between 2.5 ms and 3.2 ms .

The electronic system 1000 may further include a communication unit 1400, such as an RF, WiFi and/or Bluetooth unit. The communication unit may be provided as a communication interface between the system or drug delivery device and the outside, such as other electronic devices such as mobile phones, personal computers, laptops, etc. For example, dosage data can be transmitted to an external device via the communication unit. The dose data can be used in a dose record or dose history established in an external device. The communication unit may be configured for wireless or wired communication.

The electronic system 1000 may further include a power source 1500, such as a rechargeable battery or a non-rechargeable battery. The power supply 1500 may provide power to corresponding units of the electronic system.

When the system is in the first state, eg, the motion sensing unit and the communication unit are both inactive, the current consumption may be 20OnA. When (only) the motion sensing unit is active, the power consumption may be 0.85mA. When the communication unit (eg, in addition to the motion sensing unit or only the communication unit) is active, the power consumption may be 1.85mA.

Although not explicitly depicted, the electronic system may include a preferably permanent and/or non-volatile storage unit or memory unit that may store data related to the operation of the drug delivery device (e.g. dose history data) .

In one embodiment, the electronic control unit 1100 may be configured to reduce the power consumption of the corresponding unit, ie to switch the unit back to the first state. For example, if an event associated with the unit (e.g., a motion sensing event for a motion sensing unit) occurs after the unit has switched from a first state to a second state and/or after a use signal has been generated This is appropriate if it does not occur within the predetermined time interval. The monitoring of the time interval may be achieved by a timer unit (not explicitly shown) operatively connected to the electronic control unit. In case there is no signal generated by the motion sensing unit within a predetermined time interval after using the signal, the entire system may switch to the first state again. This interval can be greater than or equal to one of the following values: 0.2s, 0.5s, 1s, 5s, 10s, 15s, 20s, 25s, 30s.

It goes without saying that the electronic system 1000 may include further electronic units than those shown, such as other sensing units that sense or detect different quantities or events than the relative movement detected by the motion sensing unit.

Corresponding elements may be integrated in the user interface member 1600, e.g., dose setting and/or delivery buttons of the electronic system (e.g., the knob 12 of the previously discussed device), which are hereinafter incorporated The embodiments depicted in more detail in Figures 31A and 31B are discussed in more detail but are preferably present in either of the embodiments discussed below.

The usage detection unit 1300 conveniently has lower power consumption than the motion sensing unit 1200 when it is active when operable to generate a usage signal (eg, a set signal and/or a delivery signal).

When investigating the operation of a trigger switch arrangement with the switch 800 discussed further above, it has been noted that designing such a trigger switch arrangement is challenging, for example, because axial movement is used to trigger the switch. For example, there is a need to ensure that switching is triggered before commencing delivery operations (eg, before the adapter is disengaged). Furthermore, the switch may be subject to considerable axial displacement, as the clutch needs to be disengaged by relative axial movement after the switch is activated, which may place a considerable load on the switch. These considerations make the design of axial trigger switches rather complex and potentially unreliable.

In the following, some embodiments are discussed that can address the shortcomings of existing systems. Also, it may be desirable to provide other embodiments of the system configured to wake up other electronic components of the system (only) when operation of the respective components is required. In general, systems having configurations that allow one or more other electronic components to be woken from a low power state or sleep state will be discussed below.

Figure 21 illustrates an embodiment of the electronic system during operation of a device utilizing the electronic system based on four different representations A to D. In this embodiment, when the use signal is generated, it is determined that a corresponding operation (in this example a dose delivery operation, but equally possible a dose setting operation) has been initiated or started. This is preferable to triggering the wake-up process of the motion sensing unit via axial movement of a user interface member (eg injection button). Axial triggered movement of the user interface member may occur unintentionally, for example due to parts in a handbag hitting and moving a button while the user is walking around, whereas the relative movement required to actually perform the desired operation is less likely to occur unintentionally. This embodiment uses the relative movement of two components that occurs during dose delivery operation to switch the electronic system from a first, lower power consuming state to a second, higher power consuming state (where, for example, the motion sensing unit and/or communication unit is powered on). Integrating the switching process into the dose delivery operation has the advantage that in case the currently dispensed dose should be monitored via the motion sensing unit, the activation of the motion sensing unit can take place immediately if required (actually only when it should be monitored). Occurs after the operation has already started). Of course, it should be understood that a similar switching operation or the same switching operation may also be performed during the dose setting operation. However, the following description focuses on the dose delivery operation. Fig. 21 shows a perspective view of components of an electronic system related to the disclosed concept in the upper part and a top view of these components in the lower part. The different representations A to D illustrate different relative positions of the components during the dose delivery operation.

Representation A shows the situation when a dose has been set and before the dose delivery operation begins. A schematic illustration of housing 10 , first member 1780 and second member 1790 is depicted. Instead of being part of the housing 10, the outer portion may also be part of the first member and/or part of the user interface member 1600, as will become clear from a brief review of the representations in Figures 31A and 31B. The first member and the second member are part of a dose setting and drive mechanism of or for a drug delivery device. For example, the first member 1780 may be a dial sleeve or a number sleeve or a member axially and/or rotationally locked thereto, and the second member 1790 may be a drive sleeve or a user interface member (e.g., dose and and/or injection button). At least a section of the second member 1790 may be received in the first member 1780 .

For dose delivery, the first member 1780 moves (eg, rotates) relative to the second member 1790 . The second member may directly or indirectly engage with the piston rod to drive the dose delivery operation. The first member 1780 and the second member 1790 may co-rotate relative to the housing 10 during dose setting. Thus, these components may be rotationally locked relative to each other, such as by an adapter interface established during dose setting (eg via mating teeth on the two components, not shown). The adapter interface may be released during and/or for dose delivery. With the first member and/or the second member protruding from the housing during the dose setting procedure, the length of the device may be increased by an amount proportional to the size of the set dose. However, the disclosed concept will also work without such a dial extension during dose setting. During dose setting, the dose setting member (e.g., the user interface member 1600 which may be integrated into the second member) may for example change in increments (e.g., in integer multiples of unit setting increments) relative to the housing 10 spins. This may be achieved via a dose setting interface, eg a ratchet interface (not explicitly shown) which sets the spacing in unit setting increments. Such an interface may be formed between the first member 1780 and the housing, or between another member that is stationary during the dose setting procedure and a member that is movable (e.g. rotatable) relative to the stationary member during setting . The dose setting interface may define stable positions of the respective member relative to the housing that are angularly separated by one unit setting increment. For example, one unit setting increment may correspond to a rotation angle of 15°. Thus, two stable rotational positions may be angularly separated by 15°.

To switch the electronic system from the first state to the second state, this concept utilizes the use signal generating interface to generate the use signal before the first member and the second member are rotated relative to each other by one unit increment, as will be discussed further below. The use signal generating interface is also an incrementally changing interface, and preferably incrementally changes or sets the pitch in the same way as the dose setting interface, or may have finer pitches or smaller increments. In the depicted embodiment, the first member 1780 is provided with circumferentially disposed ratchet recesses 1800 . Two adjacent ratchet pockets are separated by ratchet teeth 1805 . Corresponding teeth 1805 are arranged circumferentially. In the depicted embodiment, the ratchet recess 1800 defines 24 stable positions distributed over 360°, ie, two stable positions separated by an angle of 15°. The respective ratchet recesses or the teeth 1805 delimiting these recesses may be oriented radially, ie the teeth may have radial free ends. The teeth may point inwards. Instead of the first member comprising a ratchet, the usage signal generating interface member 1880 may be provided with a ratchet which is at least rotationally locked to the first member 1780, which may be a dial sleeve or a number sleeve, for example. In the depicted embodiment, two adjacent ratchet pockets are bounded by differently sloped surfaces, a steep surface and a less steep surface. Such a ratchet interface is arranged to define a unidirectional interface, wherein relative rotation between the two parts is only possible in one direction of rotation. Thus, the interface can be used to block rotation in other directions, which can increase the safety of devices employing the system. In this configuration, rotation of the first member 1780 relative to the second member 1790 is permitted in a counterclockwise direction. Conveniently, the allowed rotation is that which occurs during the dose delivery operation. Therefore, the adapter interface must be released and part of the dose delivery operation must have been performed before the system is switched to the second state.

Additionally, the system includes a switch feature 1810, eg, a pin. The switch feature 1810 is movable, eg, radially, relative to the ratchet recess 1800 in response to rotation of the first member 1780 relative to the second member 1790 . The switch feature conveniently shuttles between two different positions. In a first position (eg, a radially outward position), the feature engages the ratchet recess 1800 and in a second position (eg, an inward position), the feature engages an end surface of a ratchet tooth. If the first member 1780 is rotated relative to the second member 1790, the switch feature 1810 is displaced inwardly (e.g., radially inwardly) from the first position to second position. The switch feature 1810 may be directed such that it moves only linearly (eg, in a radial direction or primarily in a radial direction) in response to rotation of the first member 1780 . For this purpose, a guide groove 1820 (eg, a linear groove) is provided in the second member 1790 . The free end of the switch feature may have a shape complementary to the ratchet recess. Switch features 1810 may be snugly received in corresponding ratchet recesses 1800 . Switch feature 1810 may be rotationally locked to second member 1790 . The switch feature may be radially oriented or arranged such that it defines an angle to the radial direction. The switch feature may be electrically insulating, eg, plastic.

The system further includes a first electrical contact feature 1830, eg, a resiliently displaceable feature. Features 1830 may be metal features and/or contact bars. The system further includes a second electrical contact feature 1840, eg, a resiliently displaceable feature. Features 1840 may be metal features and/or contact bars. Corresponding contact features may be secured to second member 1790 . The corresponding feature may have a free end and/or a portion that is displaceable relative to a portion of the corresponding feature fixed to the second member 1790 . The first contact feature 1813 is arranged to move towards the second feature 1840 when the switch feature 1810 is displaced inwardly.

In the situation depicted in representation A, the first electrical contact feature 1810 may push the switch feature 1810 outward to maintain the switch feature in engagement with the ratchet recess 1800 it is currently engaged. Thus, in representation A, the switch feature 1810 and the first electrical contact feature adjoin. However, contact features 1840 and 1830 are separate and not electrically connected.

When, starting from the situation in representation A, a dose dispensing operation involving relative rotation of the first member relative to the second member is initiated, the switch feature 1810 will be displaced inwardly. The switch feature 8010 carries with it the first electrical contact feature 1830 and moves it toward a portion of the second electrical contact feature 1840 until the contact features make mechanical and electrical contact with each other (as depicted in representation B). Through this contact, a use signal can be generated which can be used to trigger switching of the electronic system to the second state with higher power consumption, as already discussed above. For example, two contact features may be conductively connected to the power source 1500, and current as a usage signal flows only if these contact features are conductively connected. The use signal is preferably generated when the first member has rotated less than one unit increment relative to the second member, as depicted in representation B. Preferably, the piston rod of the dose setting and drive mechanism has been displaced (eg driven by user force transmitted to the piston rod from the user via the second member 1790) before the use signal is generated to begin dispensing the first dose from the container of the device. Drugs in unit increments. Adjoining portions of the first contact feature 1830 and the second contact feature 1840 are displaced together by the switch feature 1810, as depicted in representation C. This ensures that the usage signal is generated under all tolerance conditions. As rotation continues, the switch feature 1810 is again allowed to move outward into engagement with the next ratchet recess 1800 . This movement is driven by the spring force provided by the first contact feature 1830 . Thus, after a rotation of one unit increment (signal generating increment) has been completed, the switch feature 1810 rests in the ratchet recess again. Also, the second contact feature 1840 returns to its original position such that after the rotation of one unit increment has been completed, the system is in the situation depicted in representation D, except for the relative rotation of one unit increment, the Situation corresponds to that in representation A. As dose delivery continues, the features are brought into contact again during the next increment, where the signal is again generated.

Thus, the usage signal may be generated in an incrementally changing manner depending on the relative rotation between the two members 1780 and 1790 . Also, it is ensured that the use signal is generated before completing a rotation of one unit increment. Thus, if the motion sensing unit 1200 has been switched to a sensing state (wherein components of the motion sensing unit such as LED(s) and sensor(s) are powered and detect further progress in dose delivery operation During the relative rotation between the first member and the second member), an offset of one unit increment can be considered, for example, by adding an angle corresponding to one unit increment using the signal generating interface to the sensor from the motion sensing The calculation result of the rotation angle derived from the signal of the unit. Advantageously, the dose setting interface and usage signal generation interface are changed incrementally in the same way as already discussed above. However, different increments are also possible in case the signal generation interface is used to preferably set the pitch more finely (ie with smaller increments in the angular direction) than the dose setting interface. However, it is also possible to make the incremental pitch of the use signal generation interface coarser than that of the dose setting interface.

In portions of the first and second electrical contact features designed to abut to trigger usage signal generation, a protrusion or protrusion pointing from one portion to the other may be arranged. In the depicted embodiment, such a protrusion 1850 is provided on the second electrical contact feature 1840 . This also helps to guarantee the use of the signal even under extreme tolerance conditions. However, such protrusions need not be present. Alternatively, two contact features may be provided with such protrusions 1850 . Furthermore, it is also conceivable to drive the corresponding movement of the switch features and/or any movement of the corresponding contact features using a separate biasing member which is biased when the contact features abut and/or move together.

Having radially oriented ratchet features (recesses and teeth) and radially/transversely oriented switch features facilitates axial relative movement between the first member and the second member, which is useful for releasing/establishing the adapter interface and/or for Switching between dose setting operations and dose delivery operations may be necessary. However, there may also be systems that do not involve such switching of the adapter interface. To allow relative axial movement, the ratchet recess may have an axial extension sufficient to allow such movement. That is, the switch feature may be axially guided within the ratchet recess a distance corresponding to the state of the toggle adapter interface (e.g., from a connected or established state to an uncoupled or released state or vice versa. ) required distance.

Advantageously, the force required to operate the switch established by the first and second electrical contact features is as small as possible in order to avoid that the user has to apply too much force during the dose delivery operation.

In the situation depicted, throughout the dose delivery operation, the use signal is generated whenever the switch feature 1810 is displaced inwardly as it changes position from one ratchet recess to the next.

In one embodiment, the first member 1780 or the use signal generating interface member 1880 can be axially coupled (eg, locked) relative to the second member 1790 (eg, dose button and/or drive sleeve). This configuration avoids relative axial movement of the member having the ratchet feature (1800, 1805) relative to the member whose rotation should be monitored and/or the switch feature 1810. In this case, the ratchet can be displaced axially relative to the component whose rotation is to be monitored. The relative axial positions of the switch feature 1810 and the ratchet can be constant. Alternatively, the switch feature is axially displaced relative to the ratchet when the dose delivery operation is being activated or initiated.

In addition to generating one or more usage signals, the disclosed configurations can be used to generate audible and/or tactile feedback and/or prevent unwanted communication between the first member and the second member during the dispensing operation. Relative rotation in the direction of .

In this configuration, the generation of the use signal can be triggered without direct contact from the user, ie a switch that does not have to be mechanically contacted by the user. Furthermore, the event causing usage signal generation is integrated into the regular operating procedure of the drug delivery device, in particular into the dose delivery operation (after the user interface member/button has been moved into the position required for this operation and when the user interface member has reached this position), the relative movement between the first member and the second member has started. No separate user action is necessary in order to switch the electronic system to the second state. Furthermore, the usage signal increments can be matched to the dosage unit increments, which is advantageous because the switching of the state of the electronic system can be precisely tuned to the dosage unit increments.

In an alternative design, the switch feature may be pivotally mounted to the first member such that rotation of the first member causes pivotal movement in a plane perpendicular to the axis of rotation.

Figure 22 shows another embodiment of an electronic system based on two representations A and B. As will be readily appreciated, this embodiment is very similar to that discussed in connection with FIG. 21 . In this embodiment, however, the situation is slightly different with respect to the engagement of the switch feature 1810 with the ratchet defined by the ratchet recesses 1800 separated by the ratchet teeth 1805 . As has been discussed further above, in connection with the embodiment in FIG. 21 , the switch feature 1810 can be in a first axially relative position of the first member 1780 and the second member 1790 and in a second axial position of the movable members. Engages with ratchet recesses and/or ratchet teeth. The first axial position and the second axial position may be two extreme positions that the first member and the second member may have relative to each other. For example, from an initial position, the second member 1790 can move axially (eg, distally) relative to the first member 1780 until it has reached the final position. Thus, in FIG. 21 , in the end position, the switch feature 1810 is also engaged with the ratchet teeth and/or ratchet recesses. Due to the relative rotational movement between the first member 1780 and the second member 1790 during dose delivery operation, it is necessary to provide force or torque (eg by the user when the device is driven by the user) to continuously incrementally change the ratchet. However, after the initial usage signal generation, an additional usage signal may no longer be necessary, since the electronic system has switched to a state with higher power consumption, so that dose logging via the dose logging or motion sensing unit can be performed.

Therefore, it may be advantageous to reduce said force. Thus, in this embodiment shown in FIG. 22, in a first relative axial position of the first member 1780 and the second member 1790, the switch feature 1810 engages the ratchet, and between the first member and the second member The relative rotation of causes the switch feature to be displaced to generate the use signal. However, when the first member 1780 and the second member 1790 have reached the second relative axial position, the switch feature 1810 has been disengaged from the ratchet. The use signal is still generated by the relative rotation of the first member and the second member. The first relative axial position may be the conventional position of the two members, for example maintained by a biasing member such as an adapter spring. When in the second relative position, the first relative position can be established again by means of the spring, removing the reaction force, eg generated by the user.

Representation A shows an intermediate state during relative movement of the members 1780, 1790 between the first and second axial positions when the generation of the usage signal has been triggered (indicated by the adjoining contact features 1830 and 1840) . Specifically, the state in representation A in FIG. 22 corresponds to the state in representation C in FIG. 21 . However, at the end of the relative axial movement, the switch feature 1810 has disengaged from the ratchet. For example, the switch feature may be axially offset (eg, distally) from the ratchet. This situation is shown in representation B of FIG. 22 . Here, a second relative axial position between the first member 1780 and the second member 1790 is shown. As is immediately apparent, the switch feature 1810 now engages (particularly radially engages) the surface 1860 . The surface may be smooth, especially compared to the area in which the ratchet recesses 1800 and ratchet teeth 1805 are located. Surface 1860 may be cylindrical. The ramp 1870 is disposed between the surface 1860 and the corresponding ratchet recess 1800 or ratchet tooth 1805 . A ramp may be defined in an end section of a corresponding ratchet recess 1800 that engages the switch feature 1810 during relative movement of the first and second members from the first axial position to the second axial position. When viewed along the direction of movement of the switch feature 1810 relative to the ratchet recess 1800, the ramp may slope in an axial direction (eg, inwardly) to disengage the switch feature 1810 from the recess. When engaged by the switch feature 1810, the ramp can guide the switch feature 1810 in a radially inward direction until the ratchet recess 1800 is disengaged. Switch feature 1810 may then engage surface 1860 . Surface 1860 may respond to residual forces provided by elastically deformed first contact feature 1830 and/or second contact feature 1840 . Thus, in the second relative axial position between the first member and the second member, the contacts may be continuously closed and a use signal may be generated.

The contact features 1830 and 1840 need not engage each other in the second relative axial position of the first member and the second member. This may be accomplished by widening the interior of the system (eg, first member 1780 ) in the region where switch feature 1810 is disposed in the second relative axial position of the first and second members. This is not explicitly shown. In this case, an outwardly sloping ramp when viewed along the direction of movement may be provided axially between the ratchet recess 1800 and the switch feature 1810 . This ramp may be used to re-engage the switch feature with the ratchet recess 1800 when the first relative position between the first member and the second member is re-established after the delivery operation has been completed. Here, the radial width in that part of the first component in which the switching feature is arranged axially in the second relative axial position of the first component and the second component is preferably greater than between the free ends of the ratchet teeth Defined radial width.

In this embodiment, the axial extension of the ratchet recesses and/or teeth may be greater than the distance required to release the adapter interface in order to rotationally decouple the first and second members from each other. The axial extension of the ratchet recess is conveniently chosen such that it allows triggering of the use signal even under extreme tolerance conditions. The user interface member/button is movable in the distal direction from an initial position to a dose delivery position. The distance may be greater than that required to release the adapter interface.

In this embodiment, with the contact features in contact in a second relative axial position (as in representation B of FIG. 22 ), the user interface member can be used to generate a usage signal without relative rotation because the contacts are in closed in the second position. Thus, the option of the contacts not closing in the second relative axial position may be advantageous in terms of power consumption.

Figure 23 shows yet another embodiment of an electronic system based on three different representations A to C. The overall setup of the system is very similar to that disclosed further above in connection with FIGS. 21 and 22 . Therefore, the following discussion will focus on the differences.

As in previous embodiments, a first member 1780 (eg, a number sleeve, a dial sleeve, and/or components attached thereto rotationally and/or axially) and a second member 1790 (eg, , to actuate the sleeve or dose and/or injection button). Housing 10 is also depicted. During dose setting operations the first and second members may be rotationally locked to each other, but during dose delivery operations there is relative rotation. For example, the first member 1780 may rotate relative to the second member 1790 and relative to the housing 10 during dose delivery. The second member 1790 may be rotationally locked to the housing during dose delivery. As in the already discussed embodiments, the angle of rotation of the first member relative to the second member may be indicative of the size of the dose that has been dispensed.

In this embodiment, again, relative rotation between the first member 1780 and the second member 1790 is used to trigger usage signal generation. As in the embodiments described further above, a switch feature 1810 is provided for this purpose. The switch feature 1810 is generally configured in the same manner as previously discussed. However, its orientation is different because it is axially oriented (as seen in representation A), which presents an oblique view on the described elements of the system, which may of course have additional elements. The switch feature 1810 moves axially to generate a usage signal by triggering a sensor or switch, which is not explicitly shown, contrary to previously discussed embodiments. The sensor or switch may be implemented via an electrical contact feature or via a force or pressure sensor that is mechanically contacted by the switch feature in order to trigger the generation of the use signal. The use signal may be fed to the electronic control unit and may be used to trigger switching of the system into the second state by the control unit.

Switch feature 1810 is again operatively coupled or engaged with ratchet recess 1800 and/or ratchet teeth 1805 . The ratchet teeth and the ratchet recess together define a ratchet. In contrast to previous embodiments, the ratchet recesses 1800 and/or the ratchet teeth are axially oriented. For example, the free ends of ratchet teeth 1805 may be oriented in an axial direction, such as in a proximal direction. The ratchet teeth may have a helical configuration. That is, the inclined flanks of the teeth may extend helically when viewed in plan view along the axis of rotation, for example in the distal direction. When there is relative rotation between the ratchet tooth 1805 and the switch feature 1810, the switch feature may be displaced axially (eg, away from the tooth and/or outwardly relative to the ratchet recess) relative to the ratchet recess and/or the ratchet tooth. This axial movement can be used to trigger usage signals.

In this embodiment, in contrast to the previous embodiments, a (separate) signal generation interface component 1880 is explicitly shown. Such components may also be provided in the foregoing embodiments or may be omitted. The signal generating interface member 1880 or at least a portion thereof may be disposed radially or axially between the first member 1780 and the second member 1790 . A ratchet may be provided on the signal generation interface member 1880 . Signal generating interface member 1880 may be mechanically coupled to first member 1780 and/or second member 1790 . For example, signal generating interface member 1880 may be rotationally locked to that member relative to the housing and rotated relative to another member. For example, the signal generating interface member may be rotationally locked to the first member 1780 . The signal generating interface member may be axially locked or coupled to another member which preferably does not rotate relative to the housing 10 eg during dose delivery. For example, member 1880 may be axially coupled to second member 1790 . One of the first and second members to which the signal generating interface member 1880 is axially secured, locked or coupled, which may have a ring configuration, may be the member carrying a sensor or switch triggered by movement of the switch feature 1810 . When axially coupled to one of the members (eg, second member 1790 ), signal generating interface member 1880 may follow axial movement of that member, particularly in a distal direction and/or in a proximal direction.

When the signal generating interface member 1880 is rotationally locked to another of the members (e.g., the first member 1780), it can be with that member relative to the housing and/or relative to the other member (e.g., relative to the second member 1780). member 1790) rotates.

In the depicted embodiment, signal generating interface member 1880 is preferably rotationally locked to first member 1780 and may be axially locked to second member 1790 . Thus, when the adapter interface between the first member and the second member is released, for example by axially (eg, distally) displacing the second member 1790 relative to the first member 1780, the member 1880 can be maintained to The rotation of the first member 1780 is locked and the signal generating interface member moves with the second member in an axial direction relative to the first member. Rotational locking may be achieved by splines that provide rotational locking between interface member 1880 and first member 1780 (not expressly shown). Axial locking may be achieved by a circumferential groove in the second member 1790 .

The first member 1780 or signal generating interface member 1880 may be provided with an encoder surface or detection area 1890 for a motion sensing unit, such as the reflective surface or area 70a already described previously. The area between the detection areas may be a non-reflective area 70b. In the depicted embodiment, the detection region 1890 is formed by a radially outwardly projecting protrusion, where other configurations are possible. Said regions are circumferentially, preferably uniformly arranged and/or axially aligned (i.e. arranged at the same axial position), wherein said axis is conveniently the longitudinal axis of the system or the relative axis of the first member 1780 Axis of rotation of housing 10 . In other words, regions 1890 may be evenly distributed. All regions 1890 may have the same configuration (eg, angular width and/or shape).

Representations B and C again show different stages during the relative movement of the first member 1780 relative to the second member 1790 . As will be readily appreciated, when the first member 1780 is rotated, particularly in the clockwise direction, the switch feature 1810 will be axially displaced to where it is in representation B due to the interaction with the sloped side surface of the ratchet teeth 1805. Out of the ratchet recess 1800 it is currently in until it disengages from the ratchet recess 1800 (see illustration C). As rotation continues, the switch feature 1810 re-engages the subsequent ratchet recess 1800, for example due to a biasing member and/or an elastically deformable contact feature (not expressly shown), such as via a biasing member. Biasing the switch feature into engagement with the ratchet recess 1800 provides an axial (eg, distally) directed force on the switch feature 1810 . In the case shown in C, a switch, such as a microswitch, is triggered, for example by feature 1810, generating a use signal. Preferably, the operating force of the switch is low to keep the overall increase in force required to drive the system to a reasonable level. As rotation continues from representation C, the subsequent ratchet recess is engaged by the switch feature.

Figure 24 shows another embodiment of the electronic system. Figure 24 shows a cross-sectional view again showing the first member 1780 and the second member 1790 relative to which the first member rotates during dose delivery. Basically, this embodiment corresponds to the previous embodiment, which is why the description in this respect also applies to the present embodiment, as is obvious to a person skilled in the art. Therefore, the following description focuses on the differences.

Again, the first member 1780 may be a usage signal generating interface member 1880 having a ratchet with ratchet recesses and ratchet teeth 1800/1805 or another to which the usage signal generating interface member 1880 is connected, preferably rotationally locked. a component. Limited relative axial movement between the use signal generating interface member 1880 and the first member (if they are separate parts) may be permitted. Alternatively or additionally, the use signal generating interface member 1880 may be axially locked to the second member 1790 . Again, the switch feature 1810 is movably retained in the second member 1790 . The switch feature 1810 is guided linearly (eg, laterally and/or radially) relative to an axis of rotation, which in this embodiment is perpendicular to the plane represented in the cross-sectional view shown. Guide slot 1820 may receive a switch feature to guide linear movement of the switch feature.

Figure 24 illustrates the situation when the first member 1780 and the second member 1790 are co-rotating eg due to an adapter coupling between the first member 1790 and the second member, such as during dose setting. In this case, switch feature 1810 maintains the distance between contact features 1830 and 1840 . In particular, the contact feature 1830 can be resiliently displaced or deformed in the situation depicted in FIG. 24 such that the switch feature 1810 is biased toward the ratchet teeth 1805 (radially outward in the depicted situation). A radial end face (eg, a radially outward end face) of the switch feature abuts a radial end face of the ratchet teeth 1805 . The end faces of the teeth may be flat. When relative rotation between first member 1780 and second member 1790 is permitted, the biasing of contact feature 1830 moves switch feature 1810 radially and closes an electrical connection with contact feature 1840 . As rotation of member 1780 continues, switch feature 1810 again displaces contact feature 1830 away from contact feature 1840 . In this way, the usage signal is generated during the dose delivery incremental change pattern determined by the pitch of the teeth 1805 .

This embodiment has the advantage over the previously discussed embodiments that the switch feature 1810 does not have to displace the contact features 1830 and 1840 into contact with each other, preferably both contact features have a small displacement together to accommodate tolerances . Instead, the switch feature 1810 is used to keep the contact features apart during dose setting. Furthermore, only one of the contact features 1830 and 1840 has to be displaced during dose dispensing, for example to break the electrical contact again, and a corresponding force has to be provided, for example by the user.

The teeth 1805 may in this embodiment be arranged symmetrically, in particular with respect to a radially oriented axis. Because the switch feature does not engage the ratchet recess 1800 during dose setting, there is no option that this feature could be used to provide resistance during dose setting. Likewise, in the dose-dispensing configuration, when the first and second members are rotatable relative to each other, the interface between feature 1810 and the ratchet cannot provide any significant resistance to reducing the set dose, with a unidirectional Other embodiments of the coupler may provide the resistance.

The symmetrical configuration of the teeth facilitates re-engagement of the radial end faces of the switch feature 1810 with the radial end faces of the teeth after the dose dispensing operation has been completed. The flanks of the teeth may define an angle less than or equal to 30° with the radial direction and/or with an axis perpendicular to the axis of rotation. Accordingly, the teeth may be steeper than in previous embodiments in order to reliably break the connection between contact features 1830 and 1840 . When the first and second members are rotationally locked to each other, such as during dose setting, the point of contact between the switch feature 1810 and the respective ratchet tooth 1805 may be between the sloped side surfaces of the respective tooth. The contact point may be in the flat area of the corresponding tooth. If the switch feature engages the free end of the tooth after the dose delivery operation has been completed, the force required to re-engage the adapter after dose delivery need not account for the force required to displace the switch feature slightly (eg radially). This slight displacement may be necessary when re-engagement of the clutch requires a small rotational movement of the ratchet, where the switch feature is arranged between two adjacent teeth after the dose delivery movement of the piston rod has been completed.

It should be noted that this concept can of course also be applied to axially oriented switch features 1810 . In this case, the switch feature may be axially biased into engagement with the ratchet.

25A and 25B schematically illustrate another embodiment of an electronic system. The representations in the figures are very schematic and the main arrangement should be understood as the embodiment previously described with respect to the first member 1780 and the second member 1790 . Since the main function is very similar to one of the previously disclosed embodiments, the following description focuses on the differences, but is not limited thereto. The first contact feature 1830 and the second contact feature 1840 are connected to the second member 1790 and/or are configured such that they can be moved into mechanical contact with each other. The contact feature is preferably elastically deflectable. Protrusions 1850 (eg, protrusions) are disposed on the respective contact features, wherein protrusions 1850 of contact features 1830 and 1840 face each other such that they can be in mechanical and conductive contact with each other. The protrusions may facilitate defining different mechanical contact points between contact features, but may also be omitted. The contact features may be metallic, eg strips bent into desired shapes. When the contact features are electrically connected, a usage signal may be generated. The contact features may be conductively connected to the previously discussed power source 1500 .

In the depicted embodiment, a plurality of switch features 1810 are provided. One of the switch features is associated with the first contact feature 1830 and the other switch feature 1810 is associated with the second contact feature 1840 . Both switch features cooperate with a ratchet comprising ratchet teeth 1805 and ratchet recesses 1800 . Of course, as in the previously discussed embodiments, the ratchet extends circumferentially, only the portion of which is shown engaged by the switch feature 1810 in the figures. The switch characteristic is "in-phase" with respect to the ratchet. That is, the two switch features engage the ratchet recesses or cooperate with the ratchet teeth.

From the arrangement depicted in Figure 25A, when the first member 1780 begins to rotate relative to the second member 1790, such as during dose delivery, the first member rotates relative to the switch features, and due to their cooperation with the teeth, the switch features radially rotate. , especially the inward shift. This displaces the contact features relative to each other so that they can mechanically cooperate with each other to generate a usage signal. The situation is depicted in FIG. 25B when a use signal is generated and the contact features (eg, their protrusions 1850 ) are in contact with each other. When both features are displaced such that the contact features move toward each other, the absolute displacement of the corresponding contact feature relative to the ratchet can be less than the distance between the first contact feature 1830 and the second contact feature 1840, which must be determined by Overlays to create mechanical contact between these features. This is because there are two switch features that cooperate with the ratchet and both move in phase with each other (eg both inwards or both outwards) relative to the ratchet. Displacement can be translated into movement of contact features toward each other. The two switch features 1810 can also move towards each other in cooperation with the ratchet teeth. Switch features 1810 may be radially aligned, for example. The switching features may be oriented along a common axis, for example such that the axis is radially offset from or intersects the axis of rotation of the first member 1780 . The corresponding switching features 1810 are preferably guided linearly. This is not explicitly shown in the drawings. When cooperating with an associated ratchet tooth, the corresponding switch feature is biased radially outward such that as rotation of the first member 1780 continues, the corresponding switch feature is driven by the biasing force to re-engage the ratchet recess. Conveniently, said biasing is provided by displaced contact feature(s).

A protrusion 1850 or a contact area with another contact feature may be disposed proximate to the free end of the corresponding contact feature.

Starting from the mounting portion where the corresponding contact feature connects with the second member 1790, the corresponding contact feature may have the following parts:

- a first contact feature portion extending away from the mounting portion towards the free end of the respective contact feature;

- a second contact feature extending along the first contact feature (eg towards the mounting portion);

- A curved or bent portion connecting the first contact feature and the second contact feature.

The free end may be the end of the second contact feature. A protrusion 1850 may be disposed in the second contact feature.

26A and 26B illustrate another embodiment of an electronic system. This embodiment largely corresponds to the embodiment discussed in connection with Figures 25A and 25B. Therefore, the following description focuses on the differences. The main difference is that this embodiment does not use a separate switch feature 1810 in place of the contact features 1830,1840. Instead, the respective contact features 1830 , 1840 include ratchet interaction portions 1832 , 1842 . The interacting portion directly engages the ratchet teeth and/or the recess.

Starting from the mounting portion where the respective contact feature 1830, 1840 connects with the second member 1790, the respective contact feature may have the following parts:

- a first contact feature (1844, 1834) extending away from the mounting portion, preferably towards the ratchet and/or outwardly;

- Interaction portions (1842, 1832) for interacting with the ratchet, in which the contact features can be bent or kinked to enhance engagement with the ratchet recess and/or mimic the shape of the ratchet recess ;

- a second contact feature (1846, 1836) extending away from (eg, inwardly) the ratchet;

- a third contact feature (1848, 1838) that follows the second contact feature and/or extends up to the free end of the contact feature, the third contact feature may be along Extending along the first contact feature, along the interaction portion and/or the second contact feature. The third contact feature portion may comprise a free end and/or a contact area designed to be contacted by another contact feature.

Each of these parts may be preferably resiliently deflectable relative to the mounting part and/or relative to the other parts. Third contact feature portions of contact features 1840 and 1830 may face each other, especially in areas designed to make mechanical contact (eg, the area with protrusion 1850 ).

When the first member is rotated relative to the second member, the contact features are deflected such that they contact each other. For example, contact regions (eg, protrusions 1850 ) in the third region may contact each other. This situation is depicted in Figure 26B. As the rotation continues, for example due to the elasticity of the contact features, the arrangement in Figure 26A is restored.

The embodiments depicted in FIGS. 25A-26B use different engagements with ratchets to achieve displacement in a synchronized manner, that is, if one switch feature or contact feature is displaced toward the other, the other contact feature or associated The same is true for the switching characteristics of the connection. This means that the depth of the ratchet pockets can be reduced, since two different ratchet pockets or ratchet teeth facilitate relative movement. Within the constraints of using a consistent outer diameter of the signal generating interface member, the reduced depth of the ratchet recess may allow for a smaller ramp angle of the ramp surface of the tooth, especially at the surface bounding the tooth in the direction in which the first member should rotate . This may be beneficial to further reduce the dispensing force or torque that needs to be applied by the user. Also, if both engagements with the ratchet are used and the relative movement of the switch or contact features towards each other is used to generate the use signal, tolerance requirements may be lower and/or the overall stability and integrity of the system may be improved.

Furthermore, having two different positions of engagement with the ratchet may also improve the resistance provided by the ratchet against rotation in the opposite direction to the ratchet during dose delivery. This can improve the security of the device. As far as the clicker function of the ratchet is concerned, with regard to the elements that engage the ratchet (such as contact features or switch features), having two engagements potentially increases the risk that if re-engagement with the ratchet recesses does not occur precisely simultaneously, Separate click noises or tactile feedback are then generated, although only one feedback should be noticeable. This risk can be reduced if one of the switch or contact features is designed to generate a smaller or less pronounced feedback (for example, by rounding the edge of the part that engages the ratchet recess). The feedback will then be dominated by the re-engagement of another switch feature with the ratchet recess. In any case, the feedback generated at the two locations can be designed differently, for example, one feedback is more pronounced than the other feedback, which is preferably hardly noticeable or not noticeable.

Figure 27 shows another embodiment of the electronic system. Again, the basic functionality corresponds to the previously discussed embodiments, with the following description focusing on the differences. In general, this embodiment is very similar to that depicted in Figures 25A and 25B. However, in this embodiment, the two contact locations between the ratchet and switch feature 1810 are out of phase. That is, one of the switch features 1810 interacts with the ratchet teeth in that position while the other of the switch features 1810 is in that position before relative movement between the first member 1780 and the second member 1790 begins. The middle interacts with the ratchet recess or is arranged in the recess. Of course, the switch feature 1810 could also be omitted in this arrangement if the contact feature itself engages the ratchet as in Figures 26A and 26B.

Each switch feature 1810 is correspondingly associated with a contact feature 1830 . Thus, if the switch feature 1810 is displaced, the contact feature can follow this displacement in one direction (e.g., radially and/or inwardly), and/or can follow this displacement in another direction (e.g., radially). Switch feature 1810 is resiliently biased (such as radially outward) and/or transmits a biasing force to switch feature 1810 via contact feature 1830 due to its inherent resilience or due to a biasing member such as a spring. In the situation depicted in FIG. 27 , the upper switch feature 1810 cooperating with the ratchet tooth 1805 may be biased towards the ratchet tooth, eg, by a contact feature 1830 or a biasing member (eg, a spring).

In addition to the contact feature 1830 which is displaced relative to the second member 1790 when the first member 1780 is rotated relative to the second member, in this embodiment at least one further contact feature 1840 is provided. The additional contact feature 1840 may be stationary or non-movable, particularly relative to the second member 1790 . In the depicted embodiment, two additional contact features 1840 are provided. Depending on the state of the switch feature 1810 or the engaged state of the ratchet, one of the contact features 1830 (preferably only one of these contact features) mechanically contacts the other contact feature 1840 . Preferably, one additional contact 1840 feature is associated with each contact feature 1830 . In the depicted situation, a lower contact feature 1830 mechanically contacts an associated lower further contact feature 1840 .

In the depicted embodiment, contact features 1830 associated with switch features 1810 and/or the switch features are mechanically coupled to each other via coupling members 1855 . Coupling member 1855 may be disposed between contact features 1830 . In this way, movement of and/or force acting on one of the contact features 1830 or switch features 1810 may be transferred to the other contact feature 1830 or switch feature 1810 . Coupling feature 1855 may be a rigid or resilient member (such as the biasing member mentioned above). The elastic member may be a spring, such as a compression spring and/or a microspring. The coupling member 1855 may be configured to exert a laterally or radially directed biasing force relative to an axis of rotation which in this embodiment is directed perpendicular to the plane of the representation as in previous embodiments. The system may be designed such that in each stable relative rotational position between the first member and the second member one contact feature 1830 (preferably only one) is conductively connected to an associated further contact feature 1840 . As depicted, the pair of contact features 1830 can be shuttled between two different further contact features 1840 . A corresponding switch feature 1810 is preferably guided (eg, linearly guided), such as by a corresponding guide slot 1820 , wherein the corresponding guide slot can be rotationally and/or axially locked to the second member 1790 .

When, from the situation depicted in FIG. 27 , the first member 1780 is rotated eg in a counterclockwise direction, the lower switch feature 1810 is displaced radially, in particular inwardly. This disengages the lower contact feature 1830 from the associated further contact feature 1840 and transfers the load towards the upper contact feature 1830 via the coupling member 1855 (conveniently after biasing this coupling member). As the upper switch feature 1810 can then engage the subsequent ratchet recess 1800 adjoining the ratchet tooth 1805 opposite the direction of rotation, the upper contact feature 1830 can be moved to associate with the additional contact feature, for example via loose coupling member 1855 1840 contacts.

In the depicted embodiment, in each stable rotational position, there is a closed contact connection between a pair of one contact feature 1830 and one other contact feature 1840 . Conveniently, the electronic system is configured such that when the contact feature 1830 and the further contact feature 1840 are brought into mechanical contact with each other, a usage signal is generated. Afterwards, the electrical connection between the power source and the pair can be interrupted in order to avoid excessive power consumption. A power source may be conductively connected to the pair of contact features 1830 and further contact features 1840 that are not currently conductively connected. This can be achieved eg by suitable switching circuits in the electronic control unit.

This embodiment can be designed such that the shuttle shape formed by the switch feature and contact feature 1830 together with the coupling member 1855 is only rotated by an angle corresponding to a number of unit setting increments (eg, two unit increments). Each end of the piece changes position relative to the ratchet (ie, tooth and/or recess). However, each one of the two ends changes position relative to the ratchet every one unit set increment, so that the two ends can move incrementally in an alternating manner. In this case, the elastic coupling member 1855 is preferred because, during each unit setting increment, or even at finer pitches than a unit increment, the overall length change in the shuttle is greater than when the shuttle The overall length changes when both ends of the ratchet change position relative to the ratchet (for example, from engaging a tooth to engaging a recess or vice versa).

Figure 28 shows another embodiment of the electronic system. This embodiment is represented very schematically by its key component, which is the switch feature 1810 which interacts at its two ends 1815 with a ratchet (not explicitly shown). The switch feature 1810 is conveniently elastically deformable such that rotation of the first member 1780 relative to the second member 1790 is translated into axial movement of a portion 1812 (eg, central portion) of the switch feature. The portion 1812 of the axially displaced switch feature may be axially guided, for example, in a guide groove (not explicitly shown). The switch feature 1810 converts rotational movement into axial deformation of the switch feature, also sometimes designated as a fork or toggle mechanism component. Rotational movement of the first member 1780 (not explicitly shown) moves the ends 1815 closer to each other (along the corresponding ratchet teeth) from their respective positions engaging the ratchet recesses. This results in axial displacement of portion 1812 of switch feature 1810 .

This axial shift can be used to trigger usage signals. FIG. 28 shows two configurations of switch feature 1810 . One configuration that the switch feature has before the first member begins to rotate is referenced 1810a, while in a second configuration 1810b the portion 1812 has been axially displaced relative to the ratchet and/or tip 1815 . In configuration 1810b, portion 1812 may contact a switch 1857, such as a microswitch, which when activated may cause generation of a use signal with a corresponding wake-up process of the motion sensing unit or electronic system. The switch 1857 may be mounted on a conductive carrier (eg, a circuit board), which may be disposed within a user interface member (eg, an injection or dose knob), which may be rigidly connected to the second member 1790 or integrally formed with the second member.

Figure 29 schematically illustrates another embodiment of the electronic system. Basically, the electronic system corresponds to that described in connection with the previous embodiment shown in FIG. 28 . However, as opposed to having switch 1857 contacted or triggered by portion 1812, here portion 1812 bridges the area between two electrically separated contacts (eg, contact pads). Portion 1812 is conveniently conductive on its side facing contacts 1859, so that an electrically conductive connection can be established between contacts 1859 by means of axially displaceable portion 1812 relative to ratchet teeth (not explicitly shown) . Such a conductive connection may trigger the generation of a usage signal, such as an electrical current flowing from one contact to another via conductive portion 1812 or a conductive layer provided over portion 1812 (the portions may then be electrically insulating). As opposed to using switch 1857, this implementation may facilitate meeting tighter tolerances.

Figure 30 shows another embodiment of the electronic system. As in previously described embodiments, a usage signal generation interface component 1880 is provided. This member 1880 includes a ratchet recess 1800 and ratchet teeth 1805 that define an incremental change interface that cooperates with a switch feature 1810 to generate a usage signal, as has been previously discussed. Adjacent teeth may be separated by an angle corresponding to one unit set increment. Thus, unit set increments may be equal to use signal generation increments, as discussed further above. Therefore, for some angles, the unit setting increments are used below as a reference. However, it should be noted that use signal generation increments (where they differ from unit set increments) could also be used.

The signal generating interface member 1880 is conveniently secured rotationally to the first member 1780 and axially relative to the second member 1790, as has been further discussed above. The interface that rotationally secures member 1880 to first member 1780 is accomplished by splined features 1900 (eg, axially oriented ribs). Spline feature 1900 may be provided on first member 1780 . Corresponding features on usage signal generating interface member 1880 may be arranged to engage splined features 1900 . Of course, the locations of the splined features and corresponding features engaging the splined features could also be reversed, such that the splined features are provided on member 1880 and the corresponding features are provided on first member 1780 . The first member 1780 may be engaged in a proximal region thereof using a signal generating interface member. A proximal region of the first member 1780 may be received within the use signal generating interface member 1880 .

The usage signal generation interface member 1880 is axially movable relative to the first member 1780 between a first position and a second position, wherein the first position is shown in FIG. 30 . Member 1880 may be rotationally locked relative to first member 1780 in both positions or only one of these positions. The second position may be distally offset relative to the first position, where the distal direction in FIG. 30 is a downward direction. In the second position, the axially-oriented engagement feature 1910 of the signal generating interface member may engage a corresponding feature 1920 (eg, a slot) in the first member 1780 . The engagement may establish a rotational lock between the first member and the usage signal generating interface member, or may stabilize the relative angular position between the first member 1780 and the usage signal generating interface member 1880 . This may increase the accuracy of motion sensing and/or determination of the delivered dose because the rotational orientation between the first member which is rotated during the dose delivery operation and the usage signal generating interface member 1880 is stable. Should its rotation be monitored or measured via the motion sensing unit, the usage signal generating interface member may carry a detection area 1890 for monitoring the rotational or angular position of the first member in dose delivery operation. The interface formed during movement of signal generating interface member 1880 from a first position to a second position using signal generating interface member 1880 may be self-centering, which may be achieved by a ramped surface of one of engagement features 1910 and 1920 . In the depicted embodiment, the feature 1910, which may be a tine, has a sloped surface.

The angular distribution of engagement features 1910 and/or 1920 may have a pitch determined by an angle corresponding to one use signal generation increment and/or one unit set increment where, as already discussed, one use signal generation increment corresponds to The angle can be the same as set increments of one unit. The distance that the signal-generating interface member moves axially relative to the first member 1780 may be determined by the clutch release distance (eg, d _c ) discussed further above.

In the depicted embodiment, the usage signal generation interface member 1880 provides a usage signal generation interface through the ratchet teeth and ratchet recesses and also the detection region 1890 for determining the amount of relative rotation during dose delivery. This is advantageous from a manufacturing point of view, since the structure for generating the usage signal and the structure for monitoring movement can be integrated into one component, which can be more easily integrated into the device. Detection region 1890 may be provided on an outer surface, and a signal generating interface may be provided on an inner surface of member 1880 .

Of course, this embodiment can be combined with any of the remaining embodiments set forth in this disclosure.

31A-31E illustrate another embodiment of an electronic system. The two figures show schematic cross-sectional views during different phases of operation of the electronic system. This embodiment is similar to the previously described embodiment, which is why this description focuses on the differences. Furthermore, the features disclosed herein can be applied to other embodiments.

FIG. 31A shows a first member 1780 and a second member 1790 . As in the previous embodiments, the first member is rotatable relative to the second member during dose delivery. Both members rotate together for dose setting operations. During dose delivery operations, the second member may be rotationally locked relative to the housing. In contrast to the previously described embodiments, the second member 1790 is shown in greater detail in these figures. The second member 1790 and the user interface member 1600 (eg a dose or injection knob) may be integrated into a common part or rigidly fastened to each other. However, the second member and the user interface member 1600 may also be separate components which may be movably or non-removably connected to each other. Again, the user interface components used to interact with the user for dose setting may be different from the user interface components during dose delivery. In this embodiment, the user interface member 1600 provides a surface, ie, a setting surface 1610 , that is contacted by a user for dose setting operations. The setting surface may be a side surface of the user interface member 1600 and/or face in a radial direction. Alternatively or additionally, the user interface member provides a delivery surface 1620 . The delivery surface may be a surface facing in an axial direction (eg, proximally). After the dose has been set, the delivery surface 1620 may be contacted by the user for initiating the dose delivery operation. The second member 1790 may have an interacting portion 1792 (e.g., a hollow or sleeve-like portion) configured to receive and/or interact (e.g., engage, particularly a threaded portion) with the piston rod. engaged), the piston rod is arranged to be driven by the second member during a dose delivery operation. The setting surface 1610 may be offset radially outward relative to the interaction portion 1792 .

The usage signal generating interface member 1880 is operatively connected to (eg, rotationally locked to) the first member 1780 and can be axially moved or fixed relative to the first member, as previously discussed, for example, in connection with FIG. 30 . The use signal generating interface member conveniently includes a ratchet, eg ratchet teeth and ratchet recesses 1800, 1805, respectively as already discussed previously.

The electronic system also includes switch feature 1810 . The switch feature 1810 has an interacting portion 1811 that engages the ratchet as previously described. Since the ratchet is radially oriented, as in the previous embodiments, cooperation with the ratchet results in a radial force being transmitted to the switch feature 1810 . However, in this embodiment the switch feature is mounted in the electronic system in such a way that it can pivot. In particular, switch feature 1810 is mounted to, particularly within, first member 1790 and/or user interface member 1600 using pivot portion 1814 . Pivot portion 1814 is conveniently offset axially (eg, proximally) from the interface between use signal generating interface member 1880 and switch feature 1810 . In this way, for example, when the switch feature 1810 is displaced inwardly relative to the interface member 1880, a radial force may be converted into a pivotal movement of the switch feature, particularly involving an axial component in the proximal direction. Thus, during rotation of first member 1780 and/or member 1880 relative to second member 1790 and/or housing 10 (not expressly shown in this embodiment), switch feature 1810 relative to first member 1780 and/or Or the second member 1790 pivots.

The switching feature 1810 further includes using a signal trigger portion 1816 . Use signal trigger portion 1816 may be radially spaced from pivot portion 1814 . Pivot portion 1814 may be connected to trigger portion 1816 via connection portion 1818 . The connecting portion may be axially offset, eg, distally, from the triggering portion 1816 and the pivoting portion. The pivot portion and trigger portion may be oriented axially and radially apart. The connecting portion may extend transversely, in particular with respect to the axis of rotation. Pivot portion 1814, connection portion 1818, and trigger portion 1816 may be part of a switch feature having a U-shaped cross-section. The interaction portion 1811 may extend along a main direction defined by the connection portion 1818 . Pivot portion 1814 and trigger portion 1816 may be separated by free space. In the depicted embodiment, trigger portion 1816 is designed to displace contact feature 1830 in order to trigger or generate a usage signal. In the situation in FIG. 31A , the use signal may be triggered because a contact feature 1830 may contact another contact feature on a conductor carrier 1550 such as a circuit board, eg a printed circuit board. Of course, instead of bringing another conductive feature into contact with a mechanical contact via a conductive connection to establish a use signal, a switch mechanically contactable by trigger portion 1816 could also be provided.

Conductor carrier 1550 may be held within the interior of user interface member 1600 and may be conductively connected to and/or mechanically support or carry one or more electrical or electronic components of an electronic system, such as electronic control unit 1100 (e.g., a microprocessor device or microcontroller) or a component of a motion sensing unit. After the use signal has been generated, the switch feature 1810 may be displaced back to its initial position, for example due to the elasticity of the contact feature 1830 (as already discussed previously) or another elastic feature implemented in the electronic system. This situation is shown in Figure 31B. The control unit 1100 may be mounted on the side of the conductor carrier away from the switch feature 1810 .

The space defined by the switch feature between trigger portion 1816 and pivot portion 1814 may be designed to receive electrical components 1555 of the electronic system, such as capacitors. Electrical components 1555 can be mounted on conductor carrier 1550 on the side facing away from electronic control unit 1100 . Thus, the U-shaped cross-section of the switch feature 1810 allows for a space saving arrangement within the user interface member. The inner space of the user interface member may have an inner diameter that is larger than the inner diameter of the first member and/or the second member.

The increase in distribution force can be particularly small for this configuration of the switch feature pivoted in the axial direction compared to the switch feature already described previously.

Figures 31C-31E illustrate three embodiments of switching features that may be implemented in the embodiments discussed in conjunction with Figures 31A and 31B in place of the switching feature 1810 employed therein.

Fig. 31C shows a switch feature 1810 in which the U-shaped portion is provided with an electrical contact feature 1830 for conductively connecting two contacts 1859, for example on a conductor carrier (not explicitly shown). The depicted situation shows the situation before the usage signal is generated. That is, for example, one connection to the lower right contact 1859 is broken, while the other contact 1859 may be conductively connected to contact feature 1830 . The contact feature 1830 may be formed as a leaf spring and connected to the trigger portion 1816 of the switch feature 1810 . Contact feature 1830 may be resilient such that once a conductive connection between contacts 1859 is established by the contact feature, the resilience removes this conductive connection when the switch feature reengages the ratchet recess. Contact feature 1830 may protrude radially from the switch feature relative to the axis defined by connection portion 1818 . The contact feature may have a U-shaped cross-section, especially viewed in a plane perpendicular to the axis defined by the connection portion 1818 . Contact feature 1830 may be connected to the tip of trigger portion 1816 .

FIG. 31D shows another embodiment of a switch feature 1810 in which a contact feature 1830 is oriented along the axis defined by the connection portion 1818 and has two distinct regions, each region being provided for contacting one of the contacts 1859. . When two contacts 1859 are conductively connected to contact feature 1830, a use signal is generated. The contact feature 1830 is connected to a fastening portion 1817 disposed at an end of the connecting portion remote from the pivot portion 1814 . For example, the switch feature 1810 may be molded around the contact feature 1830, or the contact feature may be secured to the switch feature in a different manner (eg, by snap fit).

Another embodiment of a switch feature 1810 is shown in FIG. 31E . This embodiment is very similar to the embodiment in Figure 3 ID. However, connection portion 1818 of switch feature 1810 is omitted and replaced by a portion of contact feature 1830 . However, the overall geometry of the structure including the switch features and associated contact features is very similar to that depicted in Figure 31D.

The term "drug" or "medicament" is used synonymously herein and describes a pharmaceutical formulation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable Accepted carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, the use of drugs or agents to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. Drugs or agents may be used for a limited period of time, or on a regular basis for chronic conditions.

As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; Stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also contemplated.

The drug or medicament may be contained in a primary package or "drug container" suitable for use with the drug delivery device. A drug container may be, for example, a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (eg, short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (eg, 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be at room temperature (eg, about 20°C) or refrigerated temperature (eg, from about -4°C to about 4°C). In some cases, the drug container can be or include a dual chamber cartridge configured to store separately two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different components). drugs), one stored in each chamber. In this case, the two chambers of the dual chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, two chambers may be configured such that they are in fluid communication with each other (eg, via a conduit between the two chambers) and allow the user to mix the two components prior to dispensing, if desired. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are dispensed into the human or animal body.

The drugs or agents contained in the drug delivery devices described herein can be used to treat and/or prevent many different types of medical conditions. Examples of diseases include eg diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic diseases such as deep vein or pulmonary thromboembolism. Further examples of diseases are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as the 2014 Rote Liste for Doctors, eg, but not limited to major groups 12 (antidiabetic drugs) or 86 (oncology drugs); and The Merck Index, 15th Edition.

Examples of APIs useful in the treatment and/or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g. human insulin, or human insulin analogs or derivatives); glucagon-like Peptide (GLP-1), GLP-1 analog or GLP-1 receptor agonist, or analog or derivative thereof; dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt thereof or a solvate; or any mixture thereof. As used herein, the terms "analogue" and "derivative" refer to a polypeptide having a molecular structure that can be modified by deletion and/or exchange of at least one amino acid residue present in a naturally occurring peptide and/or Formally derived from the structure of a naturally occurring peptide (eg the structure of human insulin) by the addition of at least one amino acid residue. The added and/or exchanged amino acid residues may be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also known as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from that of a naturally occurring peptide (such as that of human insulin) in which one or more organic substituents ( such as fatty acids) in combination with one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and/or replaced by other amino acids (including non-codable amino acids), or amino acids (including non-codable amino acids) have been added to the naturally occurring of the peptides.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

)；B29-N-棕榈酰-des(B30)人胰岛素；B29-N-肉豆蔻酰人胰岛素；B29-N-棕榈酰人胰岛素；B28-N-肉豆蔻酰LysB28ProB29人胰岛素；B28-N-棕榈酰-LysB28ProB29人胰岛素；B30-N-肉豆蔻酰-ThrB29LysB30人胰岛素；B30-N-棕榈酰-ThrB29LysB30人胰岛素；B29-N-(N-棕榈酰-γ-谷氨酰)-des(B30)人胰岛素，B29-N-ω-羧基十五酰-γ-L-谷氨酰-des(B30)人胰岛素(德谷胰岛素(insulindegludec)，

)；B29-N-(N-石胆酰-γ-谷氨酰)-des(B30)人胰岛素；B29-N-(ω-羧基十七酰)-des(B30)人胰岛素和B29-N-(ω-羧基十七酰)人胰岛素。Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-myristoyl)-des(B30) human insulin (insulin detemir,

); B29-N-myristoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N- Palmitoyl-LysB28ProB29 Human Insulin; B30-N-Myristoyl-ThrB29LysB30 Human Insulin; B30-N-Palmitoyl-ThrB29LysB30 Human Insulin; B29-N-(N-Palmitoyl-γ-glutamyl)-des(B30 ) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des (B30) human insulin (insulin degludec,

); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N - (ω-carboxyheptadecanoyl) human insulin.

艾塞那肽(Exendin-4，

由毒蜥(Gila monster)的唾液腺产生39个氨基酸的肽)、利拉鲁肽

索马鲁肽(Semaglutide)、他司鲁肽(Taspoglutide)、阿必鲁肽

杜拉鲁肽(Dulaglutide)

rExendin-4、CJC-1134-PC、PB-1023、TTP-054、兰格拉肽(Langlenatide)/HM-11260C、CM-3、GLP-1Eligen、ORMD-0901、NN-9924、NN-9926、NN-9927、Nodexen、Viador-GLP-1、CVX-096、ZYOG-1、ZYD-1、GSK-2374697、DA-3091、MAR-701、MAR709、ZP-2929、ZP-3022、TT-401、BHM-034、MOD-6030、CAM-2036、DA-15864、ARI-2651、ARI-2255、艾塞那肽-XTEN和胰高血糖素-Xten。Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide

Exenatide (Exendin-4,

A 39 amino acid peptide produced by the salivary glands of the Gila monster), liraglutide

Semaglutide, Taspoglutide, Albiglutide

Dulaglutide

rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN -9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM -034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

它是一种用于治疗家族性高胆固醇血症的胆固醇还原性反义治疗剂。Examples of oligonucleotides are eg: Milpomersen Sodium

It is a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia.

Examples of DPP4 inhibitors are vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocotropin), growth-stimulating hormone (Somatropine) (somatorelin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprolide, buserelin, nafarelin, and goserelin.

它是一种透明质酸钠。Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (such as polysulfated forms of the above polysaccharides), and/or its pharmaceutically acceptable salt. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20

It is a sodium hyaluronate.

As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized, fully human, non-human (eg, murine) or single chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment or mutant that does not support binding to an Fc receptor, eg, that has a mutagenized or deleted Fc receptor binding region. The term antibody also includes tetravalent bispecific tandem immunoglobulin (TBTI) based antigen binding molecules and/or dual variable domain antibody-like binding proteins with cross-binding domain orientation (CODV).

The terms "fragment" or "antibody fragment" refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and/or light chain polypeptides), which do not include full-length antibody polypeptides, but still include full-length antibodies capable of binding antigen at least a portion of a polypeptide. Antibody fragments may include cleaved portions of full-length antibody polypeptides, although the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, Tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, tetravalent and multivalent antibodies), minibodies, Chelated recombinant antibodies, triabodies or diabodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework regions themselves are generally not directly involved in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies may be directly involved in antigen binding or may affect the binding of one or more amino acids in the CDRs to the antigen. ability to interact.

Examples of antibodies are anti-PCSK-9 mAbs (e.g., Alirocumab), anti-IL-6 mAbs (e.g., Sarilumab) and anti-IL-4 mAbs (e.g., Dupilumab ( Dupilumab)).

Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use as a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

Those skilled in the art will understand that modifications (additions and/or additions and/or or removal), the present invention encompasses such modifications and any and all equivalents thereof.

The scope of protection is not limited to the examples given herein above. Any invention disclosed herein is embodied in every novel feature and every combination of features, in particular every combination including any feature recited in a claim, even if that feature or that combination of features is not included in a claim or embodiment. clearly stated in.

reference sign

1 device

2 devices

10 housing

12 dose knob

11 Injection button

13 dose window

14 container or container receptacle

15 pins

16 inner needle cap

17 outer needle cap

18 caps

27 outputs

28 switches

29 power supply

70 dial sleeve

Section 70a

Section 70b

71a Construction

205 grip

210 Injection button

210a Button section

210b Button section

215 Sensor arrangement

215a sensor

215b sensor

500 encoder system

700 Controller

800 switch

900 Encoder System

1000 electronic systems

1100 Electronic Control Unit

1200 motion sensing units

1300 use detection unit

1400 Communication Unit

1500 Power

1550 conductor carrier

1555 Electrical components

1600 user interface components

1610 set surface

1620 delivery surface

1780 First member

1790 Second member

1792 Interaction part

1800 Ratchet recess

1805 ratchet teeth

1810 Switch Characteristics

1810a configuration

1810b configuration

1811 Interaction part

Part 1812

1814 pivot section

1815 end

1816 Use signal to trigger part

1817 fastening part

1818 connection part

1820 guide slot

1830 First Contact Feature

1832 Interaction part

1834 Contact feature part

1836 Contact feature part

1838 Contact feature part

1840 Second contact feature

1842 Interaction part

1844 Contact feature part

1846 Contact feature part

1848 Contact feature part

1850 protrusion

1855 Connecting members

1857 switch

1859 contacts

1860 surface

1870 slope

1880 Generate interface components using signals

1890 detection area

1900 Spline Feature

1910 Joining Features

1920 Bonding Features

d _c adapter release distance

Claims (18)

CLAIMS 1. An electronic system (1000) for a drug delivery device (1, 2), said electronic system comprising: - a dose setting and drive mechanism (1780, 1790) configured to perform dose setting operations for setting a dose to be delivered by the drug delivery device and for delivering the set dose Dose delivery operations for defined doses, The dose setting and drive mechanism comprises a first member (1780) and a second member (1790), wherein the dose setting and drive mechanism is configured such that, during the dose delivery operation and/or during the During a dose setting operation, the first member moves, for example rotates, relative to the second member, - An electronic control unit (1100) configured to control the operation of the electronic system, the electronic system having a first state and a second state, wherein the electronic system is in the second state having an increased power consumption compared to the first state, - an electricity usage detection unit (1300) operatively connected to the electronic control unit, the electricity usage detection unit being configured to generate a usage signal indicating that the user has started the dose set operation or said dose delivery operation, wherein the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the use signal, and wherein The electrical usage detection unit is configured to generate the usage in response to a relative movement between the first member and the second member, preferably in response to a relative rotational movement therebetween, preferably during the dose delivery operation. Signal. 2. The electronic system of claim 1, wherein the electricity usage detection unit (1300) is configured to respond to a relative rotation between the first member and the second member during the dose delivery operation move to generate the usage signal. 3. The electronic system according to any one of the preceding claims, wherein the dose setting and drive mechanism comprises a dose member (1780), which can be moved relative to the housing (1780) during the dose setting operation 10) Rotate in integral multiples of unit set increments, and wherein one of said first member and said second member is said dose member, or wherein said first member and said second member are different from The dosage member. 4. The electronic system according to claim 3, wherein the electronic system comprises a usage signal generation interface (1800, 1805, 1810), wherein the usage signal generation interface is configured to generate one or A plurality of usage signals, and wherein said usage signal generation interface is a delta change interface, wherein said usage signal generation delta is adjusted to said unit set delta. 5. The electronic system according to any one of the preceding claims, wherein the electronic system is configured such that the use signal is after rotation of the first member (1780) has started and at the first Generated before the member has been rotated by more than a set increment of units relative to the second member (1790). 6. The electronic system according to any one of the preceding claims, wherein the electronic system (1000) comprises a movable switch feature (1810) operatively coupled to the first member (1780) ) and the second member (1790), such that rotation of the first member relative to the second member causes the switch feature to move relative to the first member and/or the Movement of the second member, and wherein the electronic system is configured such that movement of the switch feature is used to trigger generation of the use signal. 7. The electronic system of claim 6, wherein the movable switch feature (1810) is operatively coupled to the first member and/or the second member such that the first member is relatively Rotation of the second member translates into movement of the switch feature to cause generation of the usage signal, in particular at the start of the dose setting operation or the dose delivery operation. 8. The electronic system of claim 6, wherein prior to rotation of the first member (1780) relative to the second member (1790), the moveable switch feature (1810) is resiliently biased into engagement with a blocking feature (1805), wherein when the first member is rotated relative to the second member, the blocking feature is removed from the switch feature such that a biasing force can drive movement of the switch feature to cause generation of the usage signal. 9. The electronic system according to any one of claims 6 to 8, wherein the switching characteristic (1810) is guided linearly. 10. The electronic system of any one of claims 6 to 8, wherein the switch feature (1810) is pivotally mounted, and wherein movement of the switch feature is a pivotal movement. 11. The electronic system according to any one of claims 6 to 10, wherein one of said first member (1780) and said second member (1790) is provided with a ratchet, said ratchet having a circumferential arrangement teeth of the ratchet, and wherein the switch feature (1810) is arranged to cooperate with the ratchet. 12. The electronic system according to claim 11, wherein the electronic system (1000) comprises a first switching characteristic (1810) and a second switching characteristic (1810), wherein the first switching characteristic and the second switching characteristic A feature is arranged to cooperate with said ratchet. 13. The electronic system of claim 11, One of the deformable switch features (1810) engages the ratchet at different positions where rotation of the first member (1780) relative to the second member (1790) causes A portion of the deformable switch feature is axially displaced. 14. An electronic system according to any one of the preceding claims, wherein said electronic system comprises a motion sensing unit (1200), wherein said motion sensing unit is operable in said second state of said electronic system (1000) and is operable in said second state of said electronic system Inoperable is a state wherein the electronic control unit is configured to issue a command to render the motion sensing unit operable in response to the use signal. 15. An electronic system according to any one of the preceding claims, Wherein the first member and the second member are configured to move relative to the electronic system or the housing of the drug delivery device during the dose setting operation and/or during the dose delivery operation. 16. A drug delivery device (1, 2) comprising an electronic system (1000) according to any one of the preceding claims and a reservoir with drug and/or for holding the reservoir with drug in a A reservoir holder in the drug delivery device. 17. An electronic system (1000) for a drug delivery device (1, 2), said electronic system comprising: - a dose setting and drive mechanism (1780, 1790) configured to perform dose setting operations for setting a dose to be delivered by the drug delivery device and for delivering the set dose Dose delivery operations for defined doses, The dose setting and drive mechanism comprises a first member (1780) and a second member (1790), wherein the dose setting and drive mechanism is configured such that, during the dose delivery operation and/or during the During a dose setting operation, the first member moves, for example rotates, relative to the second member, - An electronic control unit (1100) configured to control the operation of the electronic system, the electronic system having a first state and a second state, wherein the electronic system is in the second state having an increased power consumption compared to the first state, - an electricity usage detection unit (1300) operatively connected to the electronic control unit, the electricity usage detection unit being configured to generate a usage signal indicating that the user has started the dose Delivery operations, where the electronic system is configured such that the electronic system is switched from the first state to the second state by the electronic control unit in response to the use signal, and wherein The electrical usage detection unit is configured to generate the usage signal in response to relative rotational movement between the first member and the second member during the dose delivery operation. 18. The electronic system of claim 17, Wherein the first member and the second member are configured to move relative to the electronic system or the housing of the drug delivery device during the dose setting operation and during the dose delivery operation.

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